MEDIcept is an international medical device, IVD, combination product, and biotechnology compliance consulting firm. For over 25 years, our unique consulting practice has assisted thousands of companies of all sizes with cost-effective Regulatory, Quality, Clinical, Auditing, and Educational services. Our experienced team of former FDA, Notified Body, and industry experts will work with you to efficiently develop or remediate a quality system, create a regulatory strategy, or establish a clinical trial, to meet your specific needs.
MEDIcept strives to provide our clients with proven, trusted, and cost-effective solutions.
F. David Rothkopf - President and Founding Managing Partner
F. David Rothkopf has 35 years of professional strategic experience in the development and regulatory control of medical devices. He is the President and Founding Principal at MEDIcept Inc., established in 1996, offering innovative, trusted, and cost-effective Quality, Regulatory, and Clinical solutions to the medical device and invitro diagnostic industries. His expertise includes technical and hands-on knowledge in a variety of regulatory, compliance management, and quality process. He has performed over 400 ISO 13485 and FDA-style audits in the past 20 years. David has submitted over sixty-five 510ks and PMAs. He has trained many medical companies and the FDA on the intricacies of Design Control, CAPA, Software Validation, Risk Management, and Hazard Mitigation throughout a product life cycle.
As the President and Managing Partner at MEDIcept, David is responsible to set vision, mission, policies and the short- and long-term strategic direction for the corporation. This includes ensuring the corporation, its officers, and employees follow the mission, policies and procedures that are in place. He oversees all the financials aspects of the company and maintains awareness of both external and internal opportunities for expansion, customers, markets, new industry developments and standards.
David is an adjunct professor at MIT advising Doctoral students in Regulatory Affairs, a mentor for MassChallenge Accelerator, MIT Idea2 program and NIH's NHLBI Catalyze Program, and now advises Doctoral students at Johns Hopkins Whiting School of Engineering on Regulatory Affairs and undergraduates at the University of Texas, Dallas and Worcester Polytechnic Institute. He is also the President of SON Medical, a shareholder advisor for two device companies and a partner in two orthopaedic device companies. Before joining MEDIcept, he was the Chief of Operations and co-Founder of Zmed and Chief of Operations and co-Founder of Mrad and was instrumental in their sale. He was the Director of Quality at Uromed and a Project Leader at Johnson and Johnson Professional.
David holds a B.S and M.S degree in Mechanical Engineering from Worcester Polytechnic Institute. He also holds an MBA from Boston University. He is a member of RAPS, ASQ, ASQ Biomedical, and ASME. He is an advisor for a Special Needs School and a non-for-profit school.
Kim Trautman - Managing Director and Vice President
Kim Trautman, former Associate Director of International Affairs at FDA, is an experienced medical device, IVD, and combination product expert with over 30 years of industry and regulatory agency experience.
As Managing Director and Vice President, Kim is an integral part of the MEDIcept executive management team. She provides strategic client consulting services, develops business relationships with new clients, and leads the MEDIcept Training Immersion Program, developing the next generation of medical device consultants.
An expert in global medical device regulations, she wrote and harmonized the current FDA Quality System Regulation. Kim was also on the FDA authoring committee for 21 CFR Part 4 and FDA Combination Product GMP guidance documents. In addition, Trautman developed the International Medical Device Single Audit Program (MDSAP) and consortium from conception through its pilot. She is a 25-year veteran of the Global Harmonization Tasks Force (GHTF) and a foundational member of the International Medical Device Regulators Forum (IMDRF).
After retiring from FDA, she established an Authorized MDSAP Auditing Organization and launched a new Notified Body for EU IVDR/MDR Designation. She currently serves on the Board of Directors at the Regulatory Affairs Professionals Society (RAPS), has been on TC 210 Working Group 1 for ISO 13485 since its 1994 inception, and is a member of the ASTM E55 Combination Product Definitions standard. Kim also serves as the College of Engineering Vice Chair for the Industry & Professional Advisory Council at Penn State.
Trautman received her M.S. in Biomedical Engineering from the University of Virginia and her B.Sc. in Molecular Cell Biology from the Pennsylvania State University.
Susan Reilly - Managing Partner
Susan has over 35 years of medical device quality system, quality engineering, and regulatory compliance experience. She has performed hundreds of Quality Management System audits and has educated medical device companies on U.S. and international standards. Her areas of expertise include QMS remediation, QMS development and implementation, CAPA programs, document management systems, and supplier management programs.
As a Managing Partner and Vice President, Susan is an integral part of the MEDIcept executive management team. In addition, she provides strategic client consulting and education services and leads the MEDIcept Quality Engineering Team.
Before joining MEDIcept in 2019, she was Founder and President of Reilly & Associates, LLC and Director of Quality Systems at MDCI. She also held Quality positions in industry at Deknatel (Pfizer) and Burron (B. Braun) Medical.
Ms. Reilly has served as an expert witness on behalf of the FDA and was an active participant in the FDA/Medical Device Industry Initiative Task Force. She was a member of the Advisory Committee for the ASQ CQA – Biomedical Certification and a past member of the AdvaMed QA Committee.
Susan was a contributing author to “The Biomedical Quality Auditor Handbook” (ASQ) and the original editor for “The Quality System Compendium – GMP Requirements and Industry Practice” (AAMI). Ms. Reilly was also a contributor to the AdvaMed “Points to Consider When Preparing for a QSIT Inspection” documents.
She is a Senior Member of ASQ and has held multiple Biomedical Division council and committee positions since 1991, including Chair. She holds a B.S. degree in Chemical Engineering from The Pennsylvania State University.
Brian Markham - Managing Partner
Brian has over 30 years of medical device and quality management systems experience. He is a seasoned FDA and ISO 13485 auditor and provides audit readiness training and consultation for his clients. His expertise includes providing quality leadership for organizations undergoing significant quality system change due to regulatory concerns, remediation, acquisition, or growth. His career began as a bench chemist developing diagnostic ELISA kits. Career experience was gained through product support, development, facility compliance, and corporate level quality assurance roles.
As VP of Quality Systems, Brian is responsible for managing quality systems support endeavors. This includes overseeing quality system implementation, quality system training, gap assessments, auditing, audit readiness, responses to regulatory findings/actions, and remediation activities.
Prior to merging with MEDIcept in 2020, he owned and operated Quality Systems in Motion, Inc. (QSIM), providing expert consultation resources to medical device, biotech, and pharmaceutical organizations facing challenging compliance concerns. Brian has served in quality leadership positions at both small and large organizations, including Bayer, Boston Scientific and Abbott Bioresearch.
He holds a Bachelor’s degree in Chemistry from Virginia Tech and an Associate’s degree in Mathematics from Bergen Community College.
L. Adelina Paunescu, Ph.D. - Managing Partner, Vice President of Clinical Services
Adelina has 20 years of medical device and invitro diagnostic clinical operations and trial management experience in various therapeutic areas. She led clinical trials globally across more than 1,400 trial centers and over 10,000 patients, and she has educated medical companies on U.S. and international clinical trial standards. Her areas of expertise include pre-clinical, feasibility, first-in-man and complex global clinical trials, post-approval studies, and post-market registries for enhancement of data collection and long-term safety. She has expertise with IDE, PMA, and 510(k) submissions for all Class devices and IVDs. She also developed numerous MDD and MDR clinical evaluation reports. In addition to medical devices, Adelina also has experience in pharmaceutical and biologics and has been involved in Investigational New Drug and Biologics License Applications submissions.
As the VP of Clinical Affairs at MEDIcept, Adelina is responsible, on behalf of the clients, for developing the clinical strategy and corresponding with the regulatory authorities for clinical matters, as well as overseeing the clinical operation group managing the execution of clinical trials.
Before joining MEDIcept, she was the Founder and President of ACMP Clinical and Regulatory Consulting, LLC since 2017 and collaborated with MEDIcept since 2019. Her prior positions include Director of Clinical Operations at Transmedics, Heartware/Medtronic, and Reflectance Medical.
Dr. Paunescu holds a M.S. degree in Physics from the University of Bucharest, Romania, and a Ph.D. in Biophysics from the University of Illinois at Urbana-Champaign.
Adelina was a contributing author to the “Future of Optical Coherence Tomography: Ultrahigh-Resolution Versus Standard-Resolution OCT” and has authored over 40 peer reviewed articles and conference presentations. She also served as manuscript reviewer to four peer reviewed scientific journals.
Scott Blood - Director of Regulatory Services
Scott Blood brings over 30 years of medical device experience to the MEDIcept team. Although Scott is the Regulatory lead here at MEDIcept, he is also well-versed in Quality Systems and Quality Engineering.
As Director of Regulatory Services, Scott leads our ability to help our clients navigate the intricate commercialization pathways of the world’s regulatory agencies, including FDA, EU Competent Authorities, UK MHRA, Health Canada to name a select few. The Regulatory team has experience with many types of hardware and software medical devices and in vitro diagnostics in over 90 different countries. Scott’s team is also adept at assessing and managing the commercialization pathways for combination devices; device/drug, device/biologic, etc.
Scott has held leadership positions in Quality, Regulatory, and Operations at several medical device companies such as Solace Therapeutics, NinePoint Medical, Candela Corporation, InfraReDx, Fossa Medical, and PercuSurge, as well as operating his own independent medical device consulting company. Scott is typically the “first Quality guy” or “first Regulatory guy” hired into an entrepreneurial medical device pursuit.
Scott is the Past Chair of the Biomedical Division of the American Society of Quality (ASQ), a former member of the Board of Directors of the Massachusetts Medical Device Industry Council (MassMEDIC), and a member of the Regulatory Affairs Professionals Society (RAPS), as well as a frequent lecturer on quality, clinical and regulatory topics relevant to the medical device industry. Scott holds a BS degree from Wentworth Institute of Technology, as well as CQE and CQA certification through ASQ and RAC through RAPS.
Jason Gromek - Partner, Senior Business Development Director
Jason has over 19 years of medical device design, quality system, quality engineering, and regulatory compliance experience. Jason’s expertise includes design control, QMS development and implementation, project management, medical device software, CAPA programs, electronic QMS implementation and validation, FDA inspections, and remediation projects. He has held various management positions, both as a consultant and in industry.
As the Senior Business Development Director at MEDIcept, Jason is responsible for managing existing and new client relationships. Day-to-day activities include contract negotiations, customer service, and making sure MEDIcept clients are satisfied with our services. Prior to moving into this role, Jason served as a Senior Quality Consultant working on quality system implementation, software systems, FDA Inspections, and warning letter remediations.
Before joining MEDIcept, Jason was the Founder and President of BioDevice Design, LLC, a medical device development company. BioDevice was a founding member organization of America Makes – National Additive Manufacturing Innovation Institute, established to promote 3D printing in manufacturing.
He was Director of Engineering and Development at Meditech Spine and worked as a medical device design consultant for O’Savage Biomechanics. While at Meditech, Jason led the initiative to obtain regulatory clearance for Hydroxy appetite PEEK. Jason holds many patents in the areas of spinal implants.
Mr. Gromek is a member of ASQ and is a Certified Biomedical Auditor and Certified Quality Auditor. Jason holds an Associate of Arts and Associate of Science degree from Lakeland Community College.
Lisa Wagner - Director of Human Resources
Lisa is an accomplished Human Resources professional holding a Senior Professional Human Resources (SPHR) certification with 20 plus years of experience leading human resources operations and organizational planning. Lisa is well-versed in employment law, performance appraisals, salary structure, and benefits program management. She is a seasoned expert at protecting company interests and building a successful company culture, promoting employee retention and performance.
As the Director of Human Resources at MEDIcept, Lisa is an integral part of the executive management team, driving the development of creative strategies to support rapid business growth with a focus on the mission, vision, and values of MEDIcept.
Before joining MEDIcept in 2021, Lisa was the Director of Human Resources for Canyon Ranch in Lenox, Massachusetts, and Starwood Hotels & Resorts Worldwide, Inc. With nearly 30 years of hospitality experience, Lisa understands the importance of communication and employee engagement.
Attending both Mount Ida College and Cornell School of Industrial & Labor Relations, Lisa has a passion for Human Resources and continuous learning. She holds both a PHR & SPHR certification and a certification in Human Resources Studies through Cornell. Lisa is a member of many human resources organizations and has previously held a seat on the Board of Directors for the Hospitality Human Resources Association of Arizona and the Berkshire Country Regional Employment Board.
Sean Yohey - Senior Director of Quality Systems
Sean Yohey has over 25 years of experience in the medical device and biopharmaceutical industry. He has extensive experience in quality management systems, including organizational resource and project management, design controls, production and process controls, risk management, corrective action and preventive action, complaint handling and medical device reporting, change controls, design verification and validation, and statistical methods. He has authored or contributed to 510(k) submissions, PMAs, NDAs, INDs, BLAs, IDE, and CE Mark submissions for medical devices and pharmaceuticals. Sean has also acted as host or co-host for 34 US FDA and OUS Inspections and over 50 audits conducted by Notified Body or Health Authorities.
As a Senior Director of Quality Systems at MEDIcept, Sean is responsible for developing and managing our quality systems and quality engineering departments. This includes assigning responsibilities and monitoring the progress of department work, developing and tracking departmental goals, ensuring project resources are secured and allocated, partnering with sales to ensure Scope of Work and Proposals are properly defined, quoted, and staffed, identifying client processes that may require improvement, correction, or additional contracted resources.
Before joining MEDIcept, he worked as an independent consultant and a Quality Systems consultant for SynerGxp. Sean has held various positions throughout his career, including General Manager for Baxter Bioscience and Miltenyi-Biotec, where he worked in corporate Quality. Sean spent the last three years as a Senior internal compliance consultant for Philips Healthcare, aiding in lifting a corporate consent decree and warning letters.
Sean holds a B.Sc. in Biotechnology from the University of California at Davis. He’s a member of RAPS, AAMI, ASQ, and AABB.
Jennifer Almy - Partner, Senior Director of Quality Systems Services
Jennifer has over 20 years of medical device quality system, quality engineering, and project management experience. She has established, maintained, and remediated Quality Management Systems for numerous medical device companies ranging from Class I wound care to Class III implantable devices. She is passionate about developing effective and efficient quality systems in compliance with U.S. and international standards, especially scaling and tailoring the system for small and early-stage companies.
As the Senior Director of Quality Systems Services at MEDIcept, Jennifer is responsible for coordinating internal and external resources to ensure client projects are delivered on-time, within scope, and within budget. This includes serving as project manager, understanding client needs, and documenting clear proposals. Jennifer is also the MEDIcept mentor for new Quality consultants and Leadership Immersion Program associates.
Before joining MEDIcept in 2014, she worked as an independent consultant and held Quality Systems Director level positions at various startup companies on both the west and east coasts. She also served in R&D as Project Manager for various projects. Her areas of expertise include QMS development and implementation, regulatory compliance, CAPA, critical success metrics and data trending, document management, training, and supplier management programs.
Jennifer holds a B.S. degree in Mechanical Engineering (with Biomedical Interest) from Worcester Polytechnic Institute, and actively volunteers as a Technical Advisor for Worcester Polytechnic Institute’s Technical Advisors Network (entrepreneurial program). She is also an officer on the New England Discussion Group for the American Society of Quality, holding officer positions since 2005. Jennifer is also a member of RAPS and volunteers as a board member of her HOA.
Carolyn Russell - Quality Management Systems Manager
Carolyn Russell has over 25 years of experience in the medical device and manufacturing industry. Although her focused area of expertise includes Quality and Compliance Management, QMS harmonization, remediation efforts, risk management, supplier management, CAPA, training, and document and change management, she has broad experience and in-depth knowledge of FDA and ISO requirements pertaining to product development, risk management, and post-market activities. In addition, she has assisted clients with Adverse Event reporting, annual reporting, UDI submissions, and FDA facility and device registrations.
As a Quality Management Systems Manager at MEDIcept, Carolyn is responsible for managing the Quality Systems department, including managing clients, assigning responsibilities, and monitoring the department's progress. Additional roles include serving as a project manager, supporting the development and management of Quality Management Systems, such as design control systems, risk management, CAPA, complaint handling, supplier management, production control, and management responsibility to meet applicable regulations. In addition, she performs internal audits, gap assessments, supplier audits, assists clients with FDA investigations and ISO assessments, and delivers customized client training and education programs.
Before joining MEDIcept, she worked as a compliance leader in the medical device and manufacturing industry (SaMD, radiology, aesthetic lasers, and cardiac devices). This includes serving as Director of Quality, Senior Manager of Quality and Compliance, and Senior Quality Manager, including designation as Management Representative and US Agent for foreign business units.
Carolyn holds a B.S. degree in Business Studies, Industrial Organizational Psychology from Southern New Hampshire University. She’s a member of the American Society for Quality (ASQ) and Regulatory Affairs Professional Society (RAPS). Carolyn is a Certified Quality Auditor through ASQ and holds a Regulatory Affairs Certificate: Medical Devices through RAPS, Lead ISO 13485 Auditor Certificate, and EU MDR Auditor Certificate.
Jose Reyes-Marquez - Quality Consultant
Jose has over 25 years of experience in medical device and pharma quality systems, quality engineering, supplier quality, engineering, and regulatory compliance within the U.S. and Puerto Rico. He is an ASQ Certified Manager of Quality/Organizational Excellence, Certified Quality Engineer, Certified Quality Auditor, and Six Sigma Green Belt.
As a Quality Systems Consultant at MEDIcept, Jose is mainly responsible for developing and managing our clients’ compliant Quality Management System (QMS) development and implementation, including but not limited to CAPA and complaints programs, document management systems, supplier management, investigations, change control management, and associated training. In addition, he performs QMS audits, and leads or assists clients during third party audits, serving as Quality Manager to continuously support the clients’ quality systems.
Before joining MEDIcept, Jose worked mostly in quality engineering roles entailing design control, risk management, CAPA, complaint handling, new product development, and validations, holding various positions such as Quality Manager, Manufacturing Engineering Manager, Quality Engineer, Supplier Quality Engineer, Remediation Project Team Lead (client under consent decree), Sr. Regulatory Compliance Specialist, Technical Services Scientist, and Process Scientist. His experience has roots within manufacturing and later with corporate oversight for companies such as Becton Dickinson, J&J, Eli Lilly, Stryker, GSK, Alcon, and Corning.
Jose is a Senior Member of ASQ, is an active committee leader and presenter for the Corning-Elmira ASQ section, and a current of the Rochester Professional Consultants Network and the Society of Hispanic Professional Engineers (SHPE) in NY. Jose also volunteers for the Hispanic Inspiring Student's Performance and Achievement (HISPA) organization as a role model, inspiring young students to pursue career and higher education goals. He holds a B.S. degree in Industrial Engineering from the University of Puerto Rico – Mayaguez Campus. He is fully bilingual in English and Spanish.
Terri Armstrong - Quality Systems Consultant
Terri Armstrong brings over 16 years of experience in Quality Management System development and maintenance (21 CFR 820, ISO 13485:2016).
Terri has experience in all aspects of Medical Device Quality, including but not limited to Quality System creation/maintenance, Managing Document Control, Training, Supplier Qualification, Change Control, Production and Process controls, Non-conforming Product, CAPA, and Auditing.
As a Quality System Report Consultant at MEDIcept, Terri is responsible for validation of automated processes. She will also be setting up and provide support for unique device identifier (UDI) implementation. As well as Quality system development and implementation, including writing/reviewing procedures for clients of all sizes. She will also assist with Corrective action remediation, Document Control Support, and preforming Quality audits.
Before joining MEDIcept, she worked as Quality Systems Manager for Gentuity, LLC. Throughout her career, Terri has held various positions as a Document Control Coordinator, Document Control and Compliance Specialist, Document Control & Regulatory Specialist, Senior Quality Analyst, and Document Specialist Lead.
Terri holds many certifications in ISO 13485:2016 and has her Lead auditor certification in ISO 13485:2003 (TPECS). She is also a member of ASQ.
David Martin, Ph.D. - Quality Systems Consultant
David Martin, Ph.D., has nearly 40 years of experience, David has worked in the US and Germany's pharmaceutical and medical device industry. David has extensive experience in all aspects of medical device and pharmaceutical quality, including but not limited to design controls, production and process controls, risk management, CAPA, Complaints/Adverse Event (AE) management, change controls, and statistical methods. He has authored or contributed to 510(k) submissions, PMAs, NDAs, INDs, BLAs, IDE, and CE Mark applications. David has acted as host or co-host in 36 FDA Inspections and over 60 audits conducted by Notified Body/Health Authorities for a dozen countries inspecting facilities in the EU.
As a Quality Systems Consultant at MEDIcept, David is responsible for developing and managing our client quality management system and regulatory affairs projects. This includes serving as project manager, supporting the QMS compliance to relevant regulations, performing audits and assessments, and reviewing and authoring Clinical Evaluation Reports.
He began his career at Lohmann Therapie Systeme in Germany. After 20 years, he returned to the US, where he worked in corporate Clinical Quality Assurance for Purdue Pharma and the Merck Research Labs. These positions were followed by a long-term staff consulting position at Schering-Plough, where he was the World-Wide Director for the EU Clinical Trial Directive initiative, spending equal time over the next 3-1/2 years between New Jersey and Belgium.
When this engagement ended, he spent a few years as Director of Regulatory Affairs and Quality Assurance at two startups. He then returned to Germany for four years as the Director of Quality Management Systems, International, for Fresenius Medical Care Deutschland GmbH, where he was responisble for implementing a Global QMS for both Medical Devices and Pharmaceutials. He last spent the last four years as an independent consultant, aiding over two dozen medical device companies attain compliance with the EU Medical Device Regulation (MDR) and the EU in vitro Diagnostic Medcial Device Regulation (IVDR), as well as directing, reviewing, and authoring Clincal Evaluation Reports (CER), Clinical Performance Reports (PER), and their ancillary documents (PMCF, PMPF, PSUR, PPRR, SSPP, etc.) in compliance with the EU MDR, EU IVDR, and MEDDEV 2.7/1, Rev. 4.
David holds a Ph.D. in Electrical Engineering and Computer Engineering from Gerhard Mercator GH Duisburg and the equivalent Bachelors (Dip. Ing) and Masters (Magister. Ing.) from the same university. David has led global projects to develop and implement quality management systems. He has authored or co-authored numerous peer-reviewed articles, patents, and white papers. David lived and worked in Germany for 24 years and is conversant in English, German, and has a working knowledge of Afrikaans.
Marion Cappadona - Quality Engineering Manager
Marion Cappadona has over 25 years of experience in the medical device industry. Marion has focused experience in Software Systems development and validation, Risk Management, and Design Control, as well as broad experience in QMS development and implementation, including EU MDR updates, CAPA and Complaint program development, document management systems, and training. In addition, she has performed numerous Quality Management System audits and assisted many clients in developing compliant Quality Management Systems.
As the Quality Engineering Manager at MEDIcept, Marion is responsible for developing and managing our Quality Engineering department including overseeing projects in the areas of Design Control process development, Design History File remediation, Risk Management, Software documentation development, eQMS software validation, Usability – Human Factor testing, Cyber Security, Process Validation, Testing facilitation (sterilization, biocompatibility, IEC 60601), Compliance training, etc.
Before joining MEDIcept, she worked as an independent consultant and a Quality Systems consultant for MDCI. Throughout her career, Marion has held various positions as a Mechanical Engineer: New Product Development, Quality Engineer, Quality Assurance/Regulatory Affairs Manager, and MIS manager.
Marion holds a B.S. degree in Mechanical Engineering/Biomedical Minor from Worcester Polytechnic Institute. She’s a member of RAPS, ASQ, ASQ Biomedical, including previously working as the webmaster. She has also held various community volunteer positions to develop and manage websites and LMS training programs.
Henry R. Hidalgo - Senior Quality Consultant
Henry Hidalgo, a senior Quality Consultant for MEDIcept, has over 20 years of medical device sterilization, quality system, quality engineering, and regulatory compliance experience. Henry’s areas of expertise include all aspects of QMS development and implementation, Medical Device sterilization, Technology Transfer programs, CAPA programs, Complaint Handling, Calibration, Internal Quality Audit programs, Clean Room validation, implementation, and monitoring, electronic QMS validation, Project Management, implementation and monitoring FDA inspections, ISO/CE Mark audits, and Microbiology test methods development and implementation.
As the Senior QA Consultant at MEDIcept, Henry is responsible for overseeing the development and execution of our client process and quality software projects. This includes serving as the technical expert for verification and validation activities, data migration verification activities, as well as data integration activities. Additionally, he has supported FDA warning letter mitigation activities which include management of CAPAs, Quality Plans and Supplier Corrective Actions. Lastly, Henry is the staff microbiologist in which he has performed Clean Room and Sterilization method assessments for various clients.
Henry has held various management positions in industry. Before joining MEDIcept, Henry was a Senior Manager of QA at Vygon US who is a leading medical device company in Neonatology and Enteral nutrition products. He was Manager of Quality Systems at Corindus Vascular Robotics and worked as a Senior Manager of Microbiology and Sterility Assurance at ConforMIS. While at ConforMIS, a leading medical device company in making patient specific knee implants, Henry launched a microbiology lab along with the validation of several test methods to perform sustaining testing for product and Clean Room monitoring activities. He also led the project to convert the sterilization method from Vapor Hydrogen Peroxide to Ethylene Oxide to accommodate the increased volume of product sales. At Corindus Vascular Robotics Henry managed the validation and implementation of Arena PLM, an electronic QMS to manage all quality system elements. He also led the project to significantly enhance the EtO sterilization output to accommodate the increased customer demand by validating a six-pallet load which used to be a one pallet load.
Mr. Hidalgo holds a Bachelor of Science degree in Biochemistry from Salem State College and has done post-graduate work in Mechanical Engineering at the University of Massachusetts-Lowell.
Stephen Gilbert - Senior Quality Engineering Consultant
Stephen Gilbert has over 30 years of experience in the medical device industry (orthopedics, radiation therapy, intraoperative x-ray, and laser therapy). His main areas of expertise are in the Product Development process and Project Management within the regulatory requirements of QS Reg, MDD, MDR, IVDD, IVDR, ISO 13485, and GxP.
As a Senior Design Quality Engineer, Stephen is responsible for aiding clients with Design Control processes including defining Requirements Specifications, Risk Management, Verification and Validation, Usability, Design Transfer and DHF compilation.
Before joining MEDIcept, he was a consultant partner for Wipro, where his main efforts were in helping companies meet MDR requirements. This included performing gap analyses and remediation of QMS and product Design History Files for domestic and international clients. He also held positions in Product Development at Stryker, Depuy-Synthes, and Zimmer. Stephen has extensive experience in design control, risk management, CAPA, complaint handling, change management, and product verification and validation, including fatigue testing, fracture analysis, FEA, cadaver sessions, competitive benchmarking, and reverse engineering. He has authored or contributed to 510(k) submissions, PMAs, PMA supplements, and IDE submissions for sterile and non-sterile Class ll and Class lll devices. Stephen also served as point contact for FDA and NB design control audits of Design History Files.
Stephen holds a Bachelors and Masters degree in Mechanical Engineering from the University of Ottawa. He has led international teams from the US and Europe, working extensively with surgeon KOL’s to identify clinical needs and develop implant and instrument systems to meet those needs. He has authored or co-authored numerous peer reviewed articles, patents, and white papers. Stephen lived and worked in Switzerland for two years and is conversant in English, French, and German.
Taylor Dieringer - Risk Management Quality Engineer
Taylor Dieringer has practiced experience in the medical device and pharmaceutical industry. Although his focused area of expertise includes design Controls, risk management, and post market surveillance, he has broad experience in QMS development and implementation, as well as process validation.
As a Risk Management Quality Engineer at MEDIcept, Taylor is focused on providing guidance respective to ISO 14971:2019, developing quality systems to embed risk-based decisions into the design control, process validation, and post-market surveillance procedures, and assisting with execution of associated tasks.
Before joining MEDIcept, he held Research and Development, and Quality Assurance positions for various medical device and pharmaceutical companies. In these roles he developed knowledge in design controls, process validation, risk management, and post market surveillance. He gained experience preparing documentation required for regulatory submissions for Class I, II, and III medical devices, developing quality systems to meet globally recognized standards, and successfully managing CAPAs related to audit findings.
Taylor holds a Bachelor of Science in Biomedical Engineering from the Milwaukee School of Engineering (MSOE). He also has completed continuing education coursework on IVDR (EU) 2017/746, ISO 13485:2016, and 21 CFR 820 from University of Californica (UC) Santa Cruz.
Natalie Vollrath - Senior Regulatory Consultant
Natalie Vollrath brings over 30 years of experience as a quality and regulatory professional in the medical device industry. She has broad experience across multiple product categories and device classes, preparing regulatory submissions and obtaining product registrations for U.S and international markets. Natalie has led ISO and FDA regulatory and compliance efforts throughout the product lifecycle and played a key role in new product introductions.
As a Sr. Regulatory Consultant at MEDIcept, Natalie assists clients with their regulatory needs, including determination of the regulatory pathways for US, EU, and other international markets, developing and preparing submissions, technical files, Pre-Submission meeting requests, non-filing justifications, and other regulatory documentation and activities.
Before joining MEDIcept, she held roles including Quality Assurance/Regulatory Affairs Manager at various companies in the medical device industry, working with a diverse range of products that included Software as a Medical Device (SaMD) and Software as a Service (SaaS).
Natalie holds a B.A degree from the University of California, San Diego as well as certificates in Systems Engineering and Biostatistics. She is Regulatory Affairs Certified through the Regulatory Affairs Professionals Society (RAPS). Natalie also holds several additional certifications through ASQ, including Certified Medical Device Auditor, Certified Quality Engineer, and Certified Software Quality Engineer.
Richelle Helman (RAC – US, EU) - Senior Regulatory Consultant
Richelle Helman has over 35 years of experience in the medical device industry. Her main areas of expertise are regulatory submissions and the product realization process. Richelle has successfully obtained worldwide regulatory clearance for numerous products and managed various large and small complex, cross-functional projects throughout her career.
With an engineering background (mechanical and biomedical), Richelle is proficient at leading teams through the product development process and writing regualtory submissions leading to successful product clearances and approvals.
As a certified Regulatory Affairs Professional and experienced certified auditor, Richelle has an in-depth knowledge of wordwide regulatory and ISO product requirements pertaining to product submissions, product development, risk management, and post-market activities.
As a Senior Regulatory Consultant at MEDIcept, Richelle is responsible for implementing, managing and leading regulatory strategy and submission activities in order to help clients achieve successful new product introductions in worldwide markets.
Before joining MEDIcept, she worked as Vice President of Quality, Regulatory and R&D with a respiratory company on the front lines of the COVID pandemic, where she successfully led these functional areas and managed the project to develop and launch the company’s next generation technology. Throughout her career, Richelle has held various positions as a Regulatory Manager, Project Manager, Corporate Development Manager, Product Development Engineer and Consultant.
Richelle holds a Bachelor’s of Science in Mechanical Engineering from Union College, a Master’s of Science in Biomedical Engineering from Boston University, a Master’s in Business Administration from Northeastern University, a Graduate Certificate in Regulatory Affairs from Northeastern University and Regulatory Affairs Certification (US, EU) from the Regulatory Affairs Professional Society (RAPS).
Terry Gower - Regulatory Affairs Engineer
Terry Gower is a quality professional with over 25 years of experience in the medical device industry. His primary expertise is design controls, risk management and process validation. In addition, Terry has implemented several compliant Quality Management Systems and led multiple Quality Management System remediation efforts in a variety of companies.
As a Regulatory Engineer, Terry’s primary responsibility is to guide clients through design control and risk management activities as they navigate their regulatory submission pathway. This includes developing design documentation, advising on design verification/design validation strategies and leading risk analysis efforts.
Prior to joining MEDIcept, Terry held both technical and leadership positions within the quality organizations of a variety of medical device organizations, ranging from startups to well recognized industry leaders. Previous positions include Quality Engineer (supporting both sustaining quality and new product development), Quality Assurance Manager and Director of Quality Systems.
Terry holds a B.S. degree in Project Management from Wentworth Institute of Technology (Boston, MA).
Jean-Marie Toher - Associate Regulatory Consultant
Jean-Marie Toher has several years of experience in the medical device industry. Though her early career focused on clinical trial management, under MEDIcept Jean has gained experience with US and EU regulations, document management systems, and auditing.
Jean is responsible for the preparation and submission of 510(k)s, non-filling justifications, Clinical Evaluation Reports, Technical Files, and Canadian License Applications under team guidance. She assists on liaising with regulatory bodies (FDA, EU, UK, Health Canada, etc.) on product submissions. Jean also aids in the evaluation and troubleshooting of client-prepared regulatory documentation, as well as assessing labeling, advertising, and promotional material.
Before joining MEDIcept, Jean was a Clinical Research Manager for Feelmore Labs, where she managed multi-site medical device clinical trials. Jean has held several internships studying psychological and neurological functioning.
Jean holds a Bachelor’s degree in Neuroscience from Boston University. She has attained a Lead Auditor Certification from Oriel Stat a Matrix.
Jerika Acosta - Director of Clinical Operations
Jerika Acosta joins MEDIcept with over 19 years of industry leadership and management experience in Phase I-IV pharmaceutical and device clinical trials. She has worked in CRO, pharma, and academic environments, including operational oversight of multi-therapeutic global programs leading to successful regulatory submissions and product launches for multiple leading organizations.
Using her scientific training and industry knowledge to support various projects in clinical development, safety, medical writing, and regulatory, Jerika has designed, managed, and executed a large number of clinical trials worldwide.
As Director of Clinical Operations at MEDIcept, Jerika’s responsibilities include providing leadership and support to all Clinical Operation team members while effectively motivating others to succeed with her strong drive to achieve results.
Before joining MEDIcept, she managed multi-compound portfolios inclusive of adult and pediatric trials in large programs. Jerika’s background includes Clinical Development, Program Management, Strategic Planning, Risk Management, and Process Excellence.
Jerika holds a B.S. degree in Pharmacology from Rutgers University and continued her studies towards her PharmD from the Ernest Mario School of Pharmacy. She’s a member of the Association of Clinical Research Professionals (ACRP).
LeRoy Stafford - Senior Clinical Data Manager
LeRoy has over 20 years of experience in medical device and pharmaceutical data management. He has worked in CRO, sponsor, and academic environments.
Throughout his career, LeRoy has led Data Management functional groups, including mentoring, and managing data management teams, building data management practices and procedures, SOP development, and data management workflows.
As the Senior Clinical Data Manager at MEDIcept, LeRoy is responsible for managing the data management process including database build, and data review and cleaning.
Before joining MEDIcept, he worked as an Associate Director of Data Management at Syndax pharmaceuticals. Throughout his career, LeRoy has worked in various therapeutic areas including oncology, cardiovascular, infectious disease, immunology, and rare disease.
LeRoy holds an MBA from Western Governor’s University.
Kirsten Ellis RN, BSN - Telehealth and Clinical Safety Specialist
Kirsten has over 22 years of experience in healthcare, with most of her career spent working as an emergency department nurse. Kirsten worked for 10 years in the emergency department at Beverly Hospital, a Level 3 Trauma Center, Stroke, and PCI Center in Beverly MA. Kirsten was actively involved in many department and hospital-wide initiatives for improvement in process and patient care. As a Team Leader and charge nurse on the night shift, Kirsten performed unit-based quality assurance/improvement duties consistent with Joint Commission standards. During her tenure at Beverly Hospital, her team was awarded the Advance for Nurses Magazine Best Nursing Team award in 2009. Kirsten was a founding member of the department's peer interview committee which led her to be a posterboard presenter at the 2011 ENA Leadership Conference in Portland, OR.
As the Telehealth and Clinical Safety Specialist at MEDIcept, Kirsten is responsible for conducting clinical assessments in a telehealth environment for patients participating in a remote clinical trial. She assesses patients for compliance and adherence to study procedures while investigating all patient-reported adverse events, maintaining records in the clinical database, and reporting to the FDA when applicable. She also assists with the development of clinical safety plans.
Before joining MEDIcept, Kirsten worked as a travel emergency department nurse in California, Washington, Oregon, Alaska, and Hawaii. During these assignments, she gained further experience and honed her skills at Magnet certified and critical access hospitals along with level II, III, and IV Trauma Centers and large teaching hospitals.
Kirsten brings her varied medical background, wide base of nursing knowledge of different patient conditions and treatments, patient communication and education skills across the age continuum to her new role at MEDIcept.
Kirsten holds a Bachelors of Science in Nursing from the University of Massachusetts, Boston.
Kristin Hunt - CRA Field Monitor
Kristin has over 13 years of experience in the clinical research industry as a Study Coordinator, Regulatory/Start Up Specialist, and Clinical Research Associate. She has worked extensively on both device and all phases of pharmaceutical trials.
Kristin’s 13+ years of experience spans over 5 years of on-site experience as a Study Coordinator and In-House Monitor and 8 years at various CROs in Study Start Up/Regulatory Services and most recently as a Clinical Research Associate. As a Coordinator and Internal Monitor, she worked on several neurology and pediatric psychiatry trials as well as an oncology registry project.
As Field CRA Monitor at MEDIcept, Kristin is responsible for monitoring all trials both remotely and on-site and ensuring adherence to Good Clinical Practices, data accuracy, investigator integrity and compliance with all study procedures.
Cheron Legault - Associate Clinical Project Manager
Cheron Legault has over three years of experience in the Medical Device Industry. She joined MEDIcept as part of MEDIcept’s Leadership Immersion Training Program. Throughout her time in the program, Cheron worked as a Clinical Trail Assistant working beside the Clinical Operations team. While in Clinical Operations, Cheron enjoyed her work as she successfully increased her responsibilities from CTA into the area of Project Management. She was then offered a permanent placement of Associate Clinical Project Manager.
Prior to Clinical Operations, Cheron’s focus was within the areas of Quality Assurance, Quality Management Systems (Part 820 and ISO 13485), Internal Auditing, Document Control and Management, CAPA Management, and Training Program Coordination. Before joining MEDIcept, Cheron began her Medical Device Quality Assurance career in 2018 at a contract manufacturer, where she applied her QMS knowledge base throughout various roles within the organization.
Cheron holds a Bachelor of Science in Medical Laboratory Science with Biotechnology Certification from the University of Rhode Island. She is currently enrolled at Northeastern University, working towards a Master’s in Regulatory Affairs and Quality Compliance (July 2022), and holds an ISO 13485:2016 Lead Auditor Certificate from Oriel STAT A MATRIX.
Sharla McAuliffe, Director of Staff Development and Training
Sharla has over 20 years of experience in Learning and Development in corporate and academic environments. She has worked in medical device, pharma, and tech spaces.
Throughout her career, Sharla has held various industry management positions. She stood up an ISO 9001 Registration for Amazon Robotics where she developed SOP’s and a Quality training program from the ground up, serving as SME, front room lead and internal auditor.
Sharla was the North American Training Lead at Draeger Medical, a leading medical device company in heart monitors, thermoregulation and safety equipment, where she supported MDSAP audits, QMR, and managed CAPA’s and Quality Plans.
Additionally, she has held the role of Senior Training Manager of Operations, Quality and Compliance at Thermo Fisher Scientific, a 24/7 CDMO in Viral Vector Services where she managed several training programs, supported CAPA’s, deviations, client audits, FDA and EMA investigations.
Sharla holds a BS in Business with an IT concentration from Bay Path University, an M.Ed. in Instructional Design from the University of Massachusetts and is a certified Project Management Professional (PMP) from the Project Management Institute.
Joel Ellis - Account Director, Business Development
Joel has over 20 years of experience in the medical device and pharmaceutical industry.
Joel has worked with In-vitro diagnostics and medical device companies, both domestic and international providing Regulatory, Quality, and Clinical business development support. His previous clients range in size from pre-market and start-up to publicly traded corporations.
As an Account Director, Business Development for MEDIcept, Joel is responsible for developing, cultivating, and managing our new and existing client relationships. This includes providing solutions to the many Regulatory, Quality, Engineering, and Clinical challenges our customers face.
Before joining MEDIcept, Joel has held various mid-level and senior management roles throughout his career. Most recently, Joel worked in the Quality and Regulatory field (Oriel STAT A MATRIX) as VP, Business Development. He has also served as Field Manager for Alcon pharmaceuticals, Trainer for Ortho Pharmaceutical, Senior VP for AdvantMED (provider reimbursement), Sr VP for Otoharmonics, Sr VP for AHAA, and President/CEO for Practice Builders (international medical marketing agency.
Joel holds a B.S. in Biology from the University of Wyoming. Joel is an active participant in US Masters Swimming competitions and a father of three children.
Michelle Walsh - Office Manager
Michelle Walsh has over 25 years of experience in office administration.
As the Office Manager at MEDIcept, Michelle oversees the daily administrative functions and serves as a liaison to the executive team, human resources, and accounting. She is also the point of contact for clients.
Before joining MEDIcept, she worked as an office administrator for a family-owned IT consulting company. While working there, Michelle was responsible for general office functions including bookkeeping, developing marketing campaigns, event planning, business development, and customer service. Throughout her career, Michelle has held various positions such as market research manager in the hi-tech industry; facilities manager and executive assistant for an engineering and environmental company; and property manager for commercial and condominium properties throughout Massachusetts. She also holds a real estate salesperson license in Massachusetts.
Michelle has a B.S. degree in Business Administration with a Minor in International Business from Framingham State University. She has also held various community volunteer positions including serving on the Board of Directors for the Blackstone River Watershed Association, an advocacy group for the Blackstone River.
Training Immersion Program
Calia Harakaly - Associate Consultant
Calia Harakaly has 5 years of experience within the biotechnology industry which has allowed her to develop skills in quality and regulatory affairs in a breadth of laboratory environments. She has background in production, research, and clinical settings. Her skill set includes knowledge of the ISO 9000 family of standards, FDA 21 CFR experience, as well as CLIA/CAP regulations.
As a participant in the Consultant Trainee program, Calia serves MEDIcept as an Associate Medical Device Consultant. Calia is training in medical device Regulatory, Quality and Clinical affairs. This includes completion of a training rotation in each consulting service area, studying client projects under the leadership of SMEs.
Calia’s career began in a Research Cells production laboratory where she supported the laboratory’s quality compliance through actionable Good Laboratory Practices, as well as via Device History Record and SOP improvement initiatives. She next took on the role of GMP Process Development manager at an Oncology research institution, working on the scientific development of novel cellular cancer immunotherapy. During her position managing a Clinical Immunology Laboratory, Calia introduced a newly developed flow cytometry-based IVD and prepared the lab for CLIA/CAP inspection readiness.
Calia graduated from North Carolina State University with a Bachelor of Science in Cellular, Molecular, and Developmental Biology and a Minor in Biotechnology.
Thomas Essak - Associate Consultant
Thomas has extensive background in Academia research, as well as patient care experience and managing a small medical device distributor. Management Systems.
As an Associate Medical Device Consultant trainee, Thomas is currently receiving extensive training in Quality, Regulatory, and Clinical Affairs. Once his training is complete, Thomas will be placed in a full-time consulting role in one of the three disciplines.
Before joining MEDIcept, Thomas worked as a laboratory technician for Northwest Labs, and as a manager of a small medical device company, Thomas DME.
Thomas holds a B.S. degree in Kinesiology from The University of Michigan. Thomas is currently pursuing his Masters in Biomedical Engineering, and anticipates to complete his degree in the spring of 2022.
Kristina Poberezhnaya - Associate Consultant
While pursuing her biomedical engineering degree, Kristina worked on three separate engineering projects that focused on developing experience in Quality Management Systems (ISO 13485, FDA 21 CFR 820.30 Design Controls, CAPA management, FDA 510k, ISO 14971 in Risk Management). Kristina was involved with developing a Design History File for each project, as well as, presenting the final medical device prototype to a large audience.
Kristina has completed her Clinical Affairs, Regulatory and Quality training. She is looking forward to undergoing rotations in these same areas to determine which specialty will be her focus.
Before joining MEDIcept, she has extensive experience providing patient care in multiple clinical settings at the Detroit Medical Center during internship opportunities. In addition, she was able to shadow physicians at the Klinički Bolnički Centar Sestre Milosrdnice in Zagreb, Croatia under the Atlantis Fellowship. Through these opportunities, Kristina has gained valuable insight into clinical settings and has developed positive relationships within the community.
Kristina is proud to hold a Bachelor of Science degree in Biomedical Engineering with a concentration in Biomechanics as a first-generation student. She is looking forward to growing in her experiences with MEDIcept.