About Our Team

F. David Rothkopf
President and Founder

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.

Brian Markham
Managing Director and Vice President, Special Projects

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 changes 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 Special Projects, Brian is responsible for managing quality systems support endeavors and special projects. 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.

Jason Gromek
Executive Vice President, Sales and Operations

Jason Gromek has over 20 years of medical device design, quality systems, quality engineering and regulatory compliance experience. Jason has been a leader and contributor of implementation and compliance activities for 21 CFR 820 and ISO 13485 compliant Quality Management Systems and has been responsible for Product Development Lifecyle activities and U.S. and EU regulatory guidance.

As Executive Vice President, Sales and Operations, Jason leads our Sales, Quality, Regulatory and Clinical teams for MEDIcept. He is positioned to establish and communicate the strategic direction of company operations. Jason works closely with MEDIcept service line managers to ensure we are constantly cultivating strong, long-term relations with our customers and partners. This includes promoting a positive MEDIcept culture throughout the organization and advancing MEDIcept Business objectives.

Jason has held various management roles, both as a consultant and in industry. Before joining MEDIcept, Jason was 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 which was 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; at the time only the second company in the world to obtain clearance. 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.

Lisa Wagner
Director, 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.

Bob Silva
Senior Director, Software Quality Engineering

Bob Silva has extensive experience with domestic and international medical device development as an engineering executive having managed collaborative engineering teams designed to effectively create customer focused solutions. His background in medical device design and development started in software and expanded over the years to provide full engineering expertise in all aspects of medical device design and development. This includes full product life cycle development from concept through design and into product manufacturing working in startup environments as well as large corporate entities. He is a strategic thinker with the engineering leadership skills and experience in product and software lifecycle development that has resulted in approved product continuing to be used in the field today.

As the Senior Director of the Software Quality Engineering team at MEDIcept, Bob is responsible for ensuring that day-to-day operations of the software QE department work collaboratively with other departments in MEDIcept, ensuring compliance related to software design and development on the various client and MEDIcept projects. This includes successfully planning and managing multiple, parallel projects to successful completion on time and within budget and to the satisfaction of MEDIcept customers.

Before joining MEDIcept, Bob held various leadership positions at companies like Draeger Medical System, KMC Systems, FluidNet/Ivenix, Infraredx and Transfusion Technologies / Haemonetics. Early in his career he was responsible for the design and development of medical device software for some of these companies resulting in product still being used in industry today. He also has experience with in the late ‘80s and early ‘90s with Symbiotics, Inc. where, as a founder, he was responsible for helping acquire venture backed funding to drive the development of an object-oriented middleware solution used to connect computers of different types together that ultimately was embedded within IBMs OS-2 operating system.

Bob holds both a B.S. and M.S. degree in Computer Science from Northeastern University.

Marion Cappadona
Senior Consultant, Software, and Systems

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 Software and Systems Senior Consultant at MEDIcept, Marion oversees the development and execution of our client non-product software projects. This includes serving as the technical expert for software and systems improvement and implementation projects, software documentation development, verification and validation activities, data migration verification activities, as well as data integration activities. Additionally, she supports and/or manages projects in the areas of Design Control process development, Design History File remediation, Risk Management, Software Design Development, Usability – Human Factor testing, Process Validation, 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 Consultant, Quality Systems

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.

Kristina Poberezhnaya
Associate Consultant, Quality Engineering

Kristina Poberezhnaya has three years of experience involving prototype building within Quality Management Systems. This includes working with ISO 13485, FDA 21 CFR 820.30 Design Controls, CAPA management, FDA 510k, ISO 14971 in Risk Management, and developing a Design History File for each project.

Kristina has recently joined the Quality Engineering team as an Associate Consultant, where she assists with developing and managing Software Quality Engineering Systems to meet FDA QSR, ISO 13485, IEC 62304, ISO 14971, ISO 62366, and other applicable regulatory requirements. Her role includes the planning and execution of non-product software implementation and validation projects including working with clients on supplier and IEC 62304 audits related to software. Kristina assists with corrective action strategy and development related to Supplier Quality Management activities and works on development to deliver customized client training and education programs related to Software Quality Engineering activities.

She has recently graduated from the MEDIcept Leadership Immersion program, where she received in-depth training and hands-on experience in Quality, Regulatory, and Clinical Affairs.

Kristina graduated from Wayne State University with a Bachelor of Science in Biomedical Engineering and a concentration in Biomechanics as a first-generation student. She is looking forward to continuing her growth in her experiences with MEDIcept.

Carolyn Russell
Director, Quality Systems

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.

Ryan Satterly
Sr. Quality Management Systems Consultant

Ryan has over 15 years of medical device R&D, quality system, quality engineering, and regulatory compliance experience. He has successfully designed and implemented quality management systems and regulatory approaches for companies, which have been reviewed and accepted by global regulatory agencies. He has performed many Quality Management System audits and has educated numerous medical device companies on US and international standards. His areas of expertise include all aspects of QMS remediation, QMS development and implementation, CAPA programs, document management systems, and integration of risk management and cybersecurity throughout the product development lifecycle.

As a Senior Consultant, Ryan is responsible for providing proven solutions in quality systems, quality engineering, regulatory affairs, risk management, human factors, cybersecurity, and clinical trials. This includes developing and implanting design controls, design change management, customer complaint programs, non-conformance and CAPA management, and associated training programs.

Before joining MEDIcept in 2023, Ryan served in Quality & Regulatory leadership roles at medical device and biotechnology companies, as well as organizations which provide products and services to the medical device and biotechnology industries. He has successfully led the submission and approval of two 510(k) packages, including pre-submission meetings, review & creation and submission and has held positions as primary contact for regulatory inspections and inquiries.

Ryan holds a master’s degree in engineering management from Case Western Reserve University. He is a member of Regulatory Affairs Professional Society (RAPS).

Jeff Groskopf
Consultant, Quality Systems

Jeff has more than eight years of medical device experience working at both large and small medical device companies. His areas of expertise include Design Controls, Risk Management, CAPA and Complaint programs, QMS Development, and Auditing.

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.

Jose Reyes-Marquez
Consultant, Quality Systems

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.

Calia Harakaly
Associate Consultant, Quality Systems

Calia Harakaly has over six 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. Her background is in production, research, and clinical settings. Calia’s skill set includes knowledge of the ISO 9000 family of standards, FDA 21 CFR experience, as well as CLIA/CAP regulations.

As an Associate Consultant within the Quality Systems team at MEDIcept, Calia is responsible for developing and managing our client’s compliant Quality Management Systems (QMS). This includes development and implementation of CAPA, nonconformance and complaint programs, document management systems, and associated training programs. Additionally, she will assist clients with audits and remediation tasks.

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 LDT 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.

Richelle Helman
Senior Director, Regulatory

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 Director, Regulatory at MEDIcept, Richelle is responsible for leading the Regulatory team in implementing regulatory strategies 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 Vice President of Regulatory, Quality and R&D, 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).

Melissa Paffenroth
Senior Consultant, Regulatory

Melissa is a forward-thinking professional with 11+ years of success in regulatory affairs and 5+ years of success in research and development. She is experienced in medical devices and IVD medical devices.

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.

Natalie Vollrath
Senior Consultant, Regulatory

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.

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.

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.

Abiodun Taiwo
Clinical Research Associate

Abiodun Taiwo is a focused Clinical Research Associate well-versed in study protocols, standard operating procedures, and general trial oversight. He has experience in various therapeutic areas, including medical devices, oncology, neurology, and infectious disease. He also has leadership experience as a mentor to new junior 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.

Thomas Essak
Associate Consultant, Clinical

Thomas is a skilled Medical Device Consultant with extensive experience in Quality, Regulatory, and Clinical Affairs. In his current role at MEDIcept as an Associate Consultant, Clinical, he is responsible for coordinating, facilitating, and participating in data management activities from initiation of protocol, study startup through database lock under the Sr. Data Manager oversight.

His duties as an Associate Consultant include supporting CRF design, review, and validation of clinical databases, assisting and maintaining project start-up documents, performing user acceptance testing for assigned projects, and preparing data transfer agreements & coordinating the receipt of data transfers. Thomas also works in authoring all database lock documentation for assigned projects, preparing data cleaning and data status documentation, including metric reports, custom reports, data review listings, reconciliation reports, clean patient tracker, etc. Additionally, he assists in SAE reconciliation, and has the ability to support a number of moderate complexity/complex trials with Sr. Data Manager supervision.

As a recent graduate of the MEDIcept Immersion Program, Thomas received in-depth training and experience in the areas of Quality, Regulatory and Clinical.

Thomas holds a Bachelors in Kinesiology from the University of Michigan, and a Masters degree in Biomedical Engineering from Wayne State University, which he completed in the Fall of 2022. He is passionate about leveraging his education and expertise to deliver high-quality consulting services and help his clients navigate the complex landscape of medical device regulation. His commitment to excellence and attention to detail ensure that his clients receive the support they need to bring their products to market successfully.

Trevor Klemann
Associate Consultant

Trevor Klemann has worked on several projects to develop experience within Quality Management Systems, including working with ISO 14971 in the risk management process and EU MDR updates for multiple devices.

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.

Danielle Short
Associate Consultant

Danielle has experience leading and managing project engineering workshops focused on foundational engineering skills both in-person and using various online platforms.

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

Brian Siroka has an aptitude for product development, design implementation, and validation. He designed and commissioned several advanced bottle handling systems in his previous role. Brian has also facilitated MHRA audit responses and performed validation of sterilization systems. Apart from his traditional knowledge, Brian holds competencies in machining, wire routing, and thermal-fluidic experimental testbed construction. He has a friendly and caring attitude, a hardworking mentality, and a passion for the field.

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.

Abby Rieck
Associate Consultant

Abby Rieck has cultivated a passion for medical device development through her previous intern experiences managing engineering projects for start-up medical device companies. As a member of the MEDIcept team, Abby continues to expand her knowledge and experience in the medical device and consulting industries.

As an Associate Consultant in MEDIcept’s Leadership Immersion Program, Abby is undertaking comprehensive training in Quality Management, Regulatory, and Clinical Affairs. This includes completion of a training rotation in each consulting service and contributing to client projects under the mentorship of subject matter experts.

Prior to joining MEDIcept, Abby completed internships with Contraline, Inc. and Embark LLC. She also held an internship position with Merge Medical Device Studio, where she contributed to the assembly of deliverable prototypes for fifteen novel medical device projects.

Abby holds a B.S. degree in Biomedical Engineering with a minor in Engineering Business from the University of Virginia.

Emily Sawtell
Associate Consultant

Emily has experience working on teams focused on the optimization of medical devices. She also has experience leading and managing cross functional teams.

Emily is an Associate Consultant at MEDIcept, participating in the Leadership Immersion Program, where she will complete rotations to train in medical device Quality, Regulatory, and Clinical Affairs. This will allow her to learn more about each sector of medical device consulting. Emily will get to apply her knowledge to projects in the different departments at MEDIcept.

Before joining MEDIcept, Emily held the position of Supply Chain Logistics Captain at Penn State THON where she coordinated with five committees to ensure that each of their events throughout the year had the correct supplies. She worked on an Inventory Team to maintain several storage spaces that housed all of THON's supplies and collaborated with donor contacts to ensure all necessary supplies for preTHON events and THON Weekend were donated. This resulted in $130K cost savings for the organization. Emily was also the Logistics Officer at Penn State Homecoming where she oversaw the Logistics Directors and committee members coordinating the planning and execution of eight major events throughout the year.

Emily holds a B.S. in both Biomedical and Mechanical Engineering from Pennsylvania State University.
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.

Elizabeth Smith
Associate Consultant

Elizabeth Smith possesses experience in product development and report generation within the personal care industry. In her previous role, she had the opportunity to delve into FDA regulations while collaborating with her team to create a medical device. Additionally, Elizabeth has experience delivering engineering presentations on a variety of topics.

Currently, Elizabeth is serving as an Associate Consultant for MEDIcept as part of the Leadership Immersion Program. In this capacity, she is gaining valuable experience in Quality, Regulatory, Clinical Affairs, and Sales. Elizabeth is completing a training rotation in each consulting service area and contributing to client projects under the guidance of subject matter experts.

Before joining MEDIcept, she worked as a research and development engineering co-op at Edgewell Personal Care in the Schick factory located in Milford, CT. During her time at Edgewell, she participated in product development sessions, conducted panelist testing, created and edited CAD designs of new and existing products, and assisted the marketing department in producing numerous videos that explained the engineering aspects of new designs. Elizabeth also served as an Engineering Ambassador for the Engineering Ambassador network, where she developed and presented opportunities in STEM to secondary schools and facilitated students’ STEM career exploration through presentations, panel discussions, and classroom visits.

Elizabeth holds a B.S. degree in Biomedical Engineering from Rensselaer Polytechnic Institute. She also minored in public health and concentrated in the biomaterials sector of biomedical engineering. During her time at Rensselaer, Elizabeth worked on various engineering projects in multiple engineering disciplines.

John Zawacki
Vice President of Commercialization

John Zawacki has over 30 years of experience in the medical device industry, leading teams commercializing products and services. He has led the development of 20 medical device products and services from within a variety of functional roles, including product development, market development, and business development. In his over 8 years in business development roles, he has sold a variety of offerings, including contract manufacturing, drug packaging, temporary staffing, and consulting services.

As Vice President of Commercialization at MEDIcept, John leads the business development team, nurturing client relationships and introducing new prospects, while working closely with service line leads and strategic partners to ensure a positive customer experience.

Before joining MEDIcept in 2023, he was Vice President of Business Development for regulatory and quality consultancy RQM+. He has also held leadership positions at standard development organization CSA Group, UMARVL consultancy, Aptar Pharma, Teleflex Medical, r4 Vascular, American Medical Systems (now Boston Scientific), and C.R. Bard (now Becton Dickinson).

John holds a B.A.Sc. degree in Mechanical Engineering from the University of Toronto. He’s an advisor for Minnesota State University’s Customer Experience Certificate Program, and a member of both RAPS and medical sales executive group SMMG. He holds multiple patents, has been a speaker at Medical Design & Manufacturing trade shows, and has contributed articles to Business Briefing, and the Canadian Journal of Anesthesia.

Mandy Lantigua
Senior Manager, Contracts and Proposals

Mandy Lantigua has over 20 years of experience in the contracts and legal field. Although her focused area of expertise includes contract management, negotiation and dispute resolution, she also has extensive experience in proposal writing and submission of high-quality RFP responses. In addition, she has many years of experience developing and creating engaging marketing materials.

As the Senior Manager, Contracts and Proposals at MEDIcept, Mandy is responsible for supporting requests for accounts, opportunity, reports and contract maintenance in Salesforce, generating client facing contracts and making improvements as needed, supporting the Marketing Department with Pardot tracking.

Before joining MEDIcept, she worked as the Director of Commercialization managing contracts and developing winning proposals. Throughout her career, Mandy has held various positions relating to contract and proposal management, contract dispute as well as general legal matters.

Mandy graduated from Florida State University.

Ava Carr
Content Creator

Ava is a recent graduate of James Madison University with a passion for the life science industry. Her degree in Integrated Science and Technology has equipped her with a strong foundation in problem-solving, technical knowledge, and excellent collaboration, teamwork, and research skills. She is eager to contribute her knowledge and skills to MEDIcept and make a meaningful impact in the life science industry.
As the Content Creator at MEDIcept Inc., Ava will be responsible for creating content for MEDIcept's communication and marketing strategy to position it as the leader in the Medical Device Consulting Services industry, as well as managing and developing various communication and marketing materials. Ava will also be responsible for analyzing complex technical topics, communicating with stakeholders, and sending emails through mass communication tools.

Before joining MEDIcept, she worked as an intern for the Biotechnology Innovation Organization where she was responsible for data analysis, marketing deliverables, and supply chain research.

Ava holds a B.S. degree in Integrated Science and Technology with a concentration in Biomanufacturing and a minor in Global Supply Chain Management from James Madison University.

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.

Jonathan Trumbull
Financial Data Analyst

Jon Trumbull has 15 years of experience in the Finance Industry as a Business and Financial Analyst. Jon is skilled in managing ongoing budgets, forecasting, and identifying variances. He is experienced with Financial Reporting and has a long history of Process Improvement at the departmental and systems levels.

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.

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.

Nick Radoux
Manager, Talent Acquisition

Nick Radoux is a Recruitment / Talent Acquisition Specialist within the Life Science industry. Nick has sourced consultants across the Americas for Quality Assurance & Regulatory Affairs. Nick has successfully sourced consultants to support projects such as remediation efforts following FDA 483’s & Consent Decrees, QMS implementations, Audits, Investigations, Regulatory Submissions, Interim management support, design quality, and CQV activities.

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.