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
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.
F. David Rothkopf
President and Founding Managing Partner
Kim Trautman - Managing Director and Vice President
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.
Managing Director and Vice President
Brian Markham - Managing Partner
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.
Managing Director and Vice President, Special Projects
L. Adelina Paunescu, PhD - VP Clinical Services
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.
L. Adelina Paunescu, PhD
Managing Director and Vice President, Clinical Services
QUALITY SYSTEMS / QUALITY ENGINEERING
Sean Yohey - Senior Director of Quality Systems
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.
Senior Director of Quality Systems
Jennifer Almy - Partner, Senior Director of Quality Systems Services
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.
Senior Director of Quality Systems Services
Carolyn Russell - Quality Management Systems Manager
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.
Director, Quality Management Systems
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.
Senior Consultant, Software and Systems
Henry R. Hidalgo - Senior Quality Consultant
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.
Henry R. Hidalgo
Senior Quality Consultant
Stephen Gilbert - Senior Quality Engineering Consultant
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.
Senior Quality Engineering Consultant
Jose Reyes-Marquez - Quality Consultant
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.
Quality Systems Consultant
Jeff Groskopf - Quality Systems Consultant
As a Quality Systems Consultant at MEDIcept, Jeff is responsible for developing and managing our client’s Quality Management Systems (QMS). This includes developing and implementing design controls, design change management, customer complaint programs, non-conformance and CAPA management, and associated training programs. He also performs client QMS and supplier audits, and prepares and assists clients during third-party audits.
Before joining MEDIcept, Jeff worked in both quality and regulatory roles. His experience includes QMS development and process improvement, design history file remediation and integration, creation of risk management files, managing CAPA and customer compliant systems, supporting new product development, creating 510(k) and Technical Files, UDI submissions, and supporting quality audits.
Jeff holds a B.S. in Biomedical Engineering from UW-Madison. He is a member of the Regulatory Affairs Professional Society (RAPS) and is ISO 13485:2016 Internal Auditor certified.
Quality Systems Consultant
Patricia Tolmos - Quality Systems Consultant
As a Quality Systems Consultant at MEDIcept, Patricia is responsible for developing and managing our client's QMS projects and provides strategic consulting and education services. This includes serving as project manager and supporting the development and management of Quality Management Systems to meet applicable compliance requirements. In addition, she performs internal and supplier audits and delivers customized training and education programs.
Before joining MEDIcept, she was the Global Quality and Regulatory Training Manager at Cytiva, ensuring that the LMS System, together with the QMS system, were properly developed and implemented in the company. Patricia has held various positions as a QMS Training Manager, QA Validation Section Head, QC Section Head, and Auditor Manager throughout her career.
Patricia holds a Master of Science degree in Advance Synthesis Organic Chemistry and two B.S. degrees in Biochemistry and Analytical Chemistry from Queen Mary University of London. She’s a member of RAPS, ASQ, ISPE, and BSi Regulations. She has also held community volunteer positions to develop, manage, and execute LMS training programs.
Quality Systems Consultant
Cynthia Weston - Document and Quality Assurance Specialist
As a Document & Quality Assurance Specialist, Cynthia will be managing the day-to-day administration of documents and records retention, creating trend reports for quality systems, identifying processes in need of improvement, correction, or resources, and manage turnkey projects.
Before joining MEDIcept, Cynthia worked as a senior document controller for a laser aesthetics company in California. She has held a variety of document control positions and enjoys document control because it is central to all the other company functions and provides a bird’s eye view of how changes affect a business.
Cynthia holds a B.S. degree in Pharmacology from the University of California in Santa Barbara.
Document and Quality Assurance Specialist
Kristina Poberezhnaya - Associate Consultant
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.
Associate Consultant, Software Quality Engineering
Calia Harakaly - Associate Consultant
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.
Associate Consultant, Quality Systems
Richelle Helman (RAC – US, EU) - Senior Regulatory Consultant
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).
Senior Director, Regulatory
Natalie Vollrath - Senior Regulatory Consultant
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.
Senior Regulatory Consultant
Melissa Paffenroth - Senior Regulator Consultant
As a Senior Regulatory Consultant, Melissa is an integral part of the MEDIcept team. She leverages her technical skill set into in her regulatory work.
Before joining MEDIcept, she was the Regulatory Manager at ZOLL Medical and ACE Surgical Supply Co., Inc., a subsidiary of Henry Schein. She also held regulatory positions at Waters Corporation and Smith & Nephew in the Endoscopy Division.
She holds a Doctorate of Science in Biomedical Engineering and Biotechnology, Master of Science in Biomedical Engineering and Biotechnology and Bachelor of Science in Plastics Engineering from The University of Massachusetts Lowell.
Senior Regulator Consultant
Jean-Marie Toher - Associate Regulatory Consultant
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.
Associate Regulatory Consultant
Kenneth Gravono - Senior Clinical Trial Associate
As the Senior Clinical Trial Associate at MEDIcept, Kenneth is responsible for supporting clinical affairs and clinical operation functions by assisting study sites with startup activities, ensuring study documentation quality, and supporting eTMF management.
Before joining MEDIcept, he worked at Arena Pharmaceuticals, where he helped maintain oversight of the CRO and the TMF as well as transitioned into a monitoring role filling in as a CRA. Kenneth has also held positions with Xencor, where he helped implement Veeva TMF systems, and PPD, where he ?????. Prior to his biotech career, he worked in the finance industry.
Kenneth holds a B.S. Degree from the University of Oregon. He also holds a teaching certificate and taught English in Spain and Thailand. During his free time, Kenneth enjoys golf and spending time outside with his family.
Senior Clinical Trial Associate
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.
Senior Clinical Data Manager
Kristin Hunt - CRA Field Monitor
Her experience spans over five years of on-site experience as a Study Coordinator and In-House Monitor, eight 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 and 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.
Kristin holds a B.A. in Psychology from University at Buffalo, State University of New York.
CRA Field Monitor
Lanre Osheau - Clinical Research Associate
Clinical Research Associate
Abiodun Taiwo - Clinical Research Associate
As a Clinical Research Associate at MEDIcept, Abiodun’s primary function is to manage clinical trial research sites to ensure trials are completed in compliance with the protocol, GCP/ ICH guidelines, FDA Regulations, MEDIcept SOPs, and overall clinical objectives.
Before joining MEDIcept, Abiodun provided functional assistance to the project team members at Premier Research with administrative, logistical, and practical issues, including the tracking, collection, distribution, and filing study documentation. He was also responsible for monitoring activities at clinical study sites to assure adherence to GCP, ICH, and SOPs.
Abiodun holds a B.S. degree in Civil Engineering from the University of Lagos, Lagos, Nigeria.
Clinical Research Associate
Thomas Essak - Associate Consultant
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.
Associate Consultant, Clinical
Evita Asumugha - Medical Writer
Evita Asumugha has more than 13 years of experience in the medical device industry. Her areas of expertise include EU MDR clinical evaluation reporting and regulatory affairs development, along with broad experience in regulatory and quality consulting services throughout the entire product lifecycle, post-market surveillance, clinical operations, and clinical audits. She has performed numerous CER audits and assisted clients in developing EU MDR training programs.
As the Medical Writer at MEDIcept, Evita is responsible for developing and managing client clinical and regulatory projects. This includes serving as a clinical writer, supporting the clinical evaluation activities, leading CER activities, conducting literature review activities, and assessing MDD to EU MDR transition process.
Before joining MEDIcept, she worked as an independent consultant and a Medical Writer for Medpoint, R&Q, Apple Healthcare, and Amicus Therapeutics. Throughout her career, Evita has held various positions as a Clinical Research Scientist, Literature Review/Clinical Analyst, Principal Medical Writer/Project Manager, and International Regulatory Affairs Consultant.
Evita holds a B.S. in Biology/Chemistry and an English Minor from the University of Houston, and two Master’s in Public Health (University of Arkansas Medical School [UAMS] College of Public Health) and Biomedical Science (University of Medicine and Dentistry of New Jersey [UMDNJ] Graduate School of Biomedical Science).
She’s a member of the Regulatory Affairs Professionals Society (RAPS), the American Medical Association (AMA), the American College of Physicians (ACP), the American Public Health Association (APHA), and the Institute for Healthcare Improvement (IHI). Evita has also held various community volunteer positions to help teach nutrition and preventative medicine to non-traditional students.
LEADERSHIP IMMERSION PROGRAM
Danielle Short - Associate Consultant
Danielle joins the team at MEDIcept and is growing her knowledge of the medical device and consulting industry. She brings her background in Biomedical Engineering and leadership and teamwork skills to the Leadership Immersion program.
As a participant in the Leadership Immersion Program, Danielle serves MEDIcept as an Associate Consultant. She is training in medical device Regulatory, Quality, and Clinical Affairs. This includes completing a training rotation in each consulting service area and contributing to client projects under the leadership of SMEs.
Before joining MEDIcept, Danielle attended the University of Delaware, graduating in May of 2022 with a Bachelor of Biomedical Engineering. While at the University of Delaware, Danielle worked on a wide variety of engineering projects in the Biomedical Engineering department and served as an undergraduate teaching assistant.
Brian Siroka - Associate Consultant
As a participant in the Leadership Immersion Program, Brian serves MEDIcept as an Associate Consultant. Brian is training in medical device Regulatory, Quality, and Clinical Affairs. This includes completion of a training rotation in each consulting service area, studying and contributing to client projects under the leadership of SMEs.
Before joining MEDIcept, he worked as a Mechanical Design Engineer at Dyco, Inc. In this position, he was responsible for designing and implementing plastic bottle handling machinery. He translated client information from the sales team into actionable engineering criteria.
Brian holds a dual B.S. degree in Mechanical Engineering and Biomedical Engineering from The Pennsylvania State University. At Penn State, he was a dedicated tour guide and THON Captain, an organization that raises money for pediatric cancer.
Trevor Klemann - Associate Consultant
As a participant in the Leadership Immersion Program, Trevor serves MEDIcept as an Associate Consultant. Trevor is training in medical device Regulatory, Quality, and Clinical Affairs. This includes completion of a training rotation in each consulting service area, studying and contributing to client projects under the leadership of SMEs.
Before joining MEDIcept, he worked as a Product Development intern for Novocure, where he worked closely with quality engineers to improve efficiency in the risk management process for tumor treating field medical devices.
Trevor holds a Bachelor of Science degree in Biomedical Engineering with a concentration in Biochemistry from The Pennsylvania State University.
SALES & BUSINESS DEVELOPMENT
Jason Gromek - Partner, Senior Business Development Director
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.
Executive Vice President, Sales and Operations
Joel Ellis - Account Director, Business Development
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.
Account Director, Business Development
MARKETING & COMMUNICATIONS
Chloe Thomas - Marketing Communications Coordinator
Chloe Thomas has over five years of experience in the marketing and communications industry. Although her area of expertise includes social media content creation and multimedia marketing, she has a broad experience in product promotion, organizational promotion, journalism, graphic design, and many other marketing and communication skills.
As the Marketing Communications Coordinator at MEDIcept, Chloe is responsible for creating and editing presentation material, designing website content, managing social media, and budgeting for promotions. Chloe will also be responsible for establishing and maintaining relationships with various teams and vendors, and working on an annual marketing plan.
Before joining MEDIcept, she worked as a Social Media Coordinator for Neat Companies. Throughout her career, Chloe has held various positions such as Social Media Coordinator, Marketing Manager, Public Relations Assistant, Admissions Assistant, and more.
Chloe holds a B.A. degree in Communication and Journalism from Lindsey Wilson College. Throughout her time at Lindsey, she was a Student Ambassador, Peer Mentor, International Student Program Ambassador and Host Family, Student Government Representative, and employed in both the Public Relations and Admissions offices. She was awarded the “Outstanding Achievement in Media Studies and Journalism” award for two consecutive years and the “Outstanding Achievement in Communication” award. Chloe has also held various community and charity volunteer positions.
Marketing & Communications Coordinator
Sharla McAuliffe - Director of Staff Development and Training
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.
Director of Staff Development and Training
Michelle Walsh - Office Manager
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.
Jonathan Trumbull - Office Manager
Jon works at multiple levels to keep the annual budget on track and identify needed areas for improvements to our ongoing financial tracking. He works to improve our ongoing need for financial forecasting and is involved with cross-functional teams to ensure the durability of our processes and procedures.
Before joining MEDIcept, Jon worked as a PMO Lead for enterprise-wide technical improvements to manage the flow of financial information between divergent vendor and internal financial record systems. He also spent two years working with government-focused systems, helping develop novel reporting tools to facilitate the best process approach for identifying areas of need across multiple states.
Jon has a Bachelor’s in Psychology and a Master’s in Organizational Development. He has trained with LEAN and is experienced in developing new procedures and tools to help increase efficiency beyond his area of control. With his financial skills, Jon brings a supervisory skill set that augments his ability to work throughout the organizational hierarchy.
Finance Data Analyst
Lisa Wagner - Director of Human Resources
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.
Director of Human Resources
Nick Radoux - Talent Acquisition Manager
As the Talent Acquisition Manager, Nick is responsible for overseeing the recruitment activities at MEDIcept. Working directly with Senior Executives and HR, Nick will support the rapid growth of MEDIcept by finding talented industry professionals who will grow with MEDIcept and continue providing trusted solutions for their vast global client base.
Before joining MEDIcept, Nick worked as a recruitment specialist for a large global staffing company. Nick built a contract recruitment desk from the ground up and generated revenues exceeding $500k. Nick acquired deep industry knowledge and an extensive network of consultants, which resulted in over 20 active consultants performing work on behalf of the company.
Nick holds a B.S. degree in Business Studies from Canterbury Christ Church University. Project Management certification, management qualifications from previous employers, and multiple sales awards/achievements.
Talent Acquisition Manager