Our regulatory consulting team provides regulatory consulting services to medical device manufacturers regardless of size and location. Our team is global and we routinely handle medical device regulatory issues around the world.
Consulting Team Services
- Regulatory Submissions (e.g., 510k submissions, CE Marking and Canadian Medical Device Licensing)
- Regulatory Compliance (e.g., mock FDA inspections, ISO 13485 certification and CAPA)
- Continuing Education Training – webinars, public and private in-house training courses.
To learn more about our consulting team and the services we provide, to schedule a call or to request a proposal, please contact Rob Packard, President at +1.802.281.4381 or by email at email@example.com.
Medical Device Academy has grown over the years and we are continuously adding new experts to our team. Interested in Joining our Team? Click Here for Consulting Opportunities
Full-time & Part-time Employees
Mary Vater – 510(k) Consultant
Mary is a biomedical engineer and consultant with Medical Device Academy. She graduated from Wichita State University and has experience in Q/A and BioMed. Mary has experience with 510k submissions for reprocessed single-use devices, sterile devices, electrical devices and standalone software. She also has experience with CE Marking and Canadian Licensing application. She served both as an engineer and the Head of Quality Assurance at Biomedical Devices of Kansas.
Email: firstname.lastname@example.org Phone: (913) 274-9899
Tifany Chesser – Executive Admin.
Tifany is the Executive Administrator for Medical Device Academy, Inc. and FDA eCopy. She is responsible for scheduling meetings with the president and other consultants on the team. She also helps to prepare 510(k) submissions and pre-submissions–including the printing of FDA eCopies and ensuring they are picked up by FedEx on-time.
Email: email@example.com Phone: (802) 779-4897
Matthew Walker – Marketing and Quality Systems Consultant
Matthew is the newest member of the team for Medical Device Academy, Inc. and FDA eCopy. He originally started helping us market our consulting services and to promote the Amsterdam 510k workshop. He is also Pro-Board certified firefighter, training officer, and at one point even an EMT. He came to us from his own consulting company where he specialized as an OSHA safety consultant for the construction industry. He holds a degree in Fire Science from Keiser University where he graduated with Honors. When not marketing Matthew works with Quality Systems doing Gap Analyses, Procedural Redlining and Editing as well as working with Quality Manuals, and CAPAs. If you are interested in co-branding or advertising opportunities with our company, please contact Matthew.
Connect on Linkedin: https://www.linkedin.com/in/matthew-walker-214718101/
Independent consultants we work with
Leo Eisner – IEC 60601 Expert
Leo is the Principal Consultant of Eisner Safety Consultants. He is a licensed professional engineer in safety engineering, an expert in product safety for medical electrical devices (IEC 60601 series of standards), has been heavily involved in standards development focused on the IEC 60601 series of standards including working on IEC 60601-1, 3rd ed. + Amendment 2 (due out late 2019), has worked for several Notified Bodies as an auditor & technical reviewer, and is an expert in CE marking for the medical device directive. He has over 30 years experience in product safety, and he routinely speaks all over the world as an international expert on the topic of electrical safety and IEC 60601-1. Read More
Nancy Knettell – Software Verification & Validation Expert
Nancy Knettell is a IEC 62304 software verification and validation expert. She added 11 new software verification and validation procedures and associated templates to Medical Device Academy’s growing library of quality system procedures. Read More
Wolfgang Huber and Yves Berquin are Co-Founders of Matrix Requirement Medical. They are software engineers experienced in the requirements for IEC 62304 and the requirements for software documentation in a 510k submission. Their company developed a web-based application to help medical devices organize documentation (requirements, specifications, use cases, tests, risk analysis) for their Design History File (DHF). The software eliminates the need to exchange word documents, maintains version control and automatically creates a traceability matrix. The company website includes testimonials for customers that use the software for creating their 510k submission documents.
Adam Shames – Founder & CEO of Core human Factors, Inc.
Adam is a human factors expert. He has an M.B.A. in International Business from the Fox School of Business and Management at Temple University and a B.S. in Human Factors Engineering and Psychology (double major). From Tufts University. He has over a decade of extensive research experience, and has conducted hundreds of usability studies with thousands of participants around the world. He has also been the principal investigator on numerous successful IRB reviewed studies. As a guest speaker, Adam will be explaining how to design and conduct human factors studies for your 510k submission.
Jonathan C. Bretz – UDI Expert
Jonathan C. Bretz, OT/L, MBA, RAC is a UDI Consultant, and has 35+ years medical device experience, including Regulatory Affairs/Compliance, Submission experience [510(k), CE Technical Files, Health Canada], Quality Systems (QSR, ISO 13485), Risk Mitigation (ISO 14971), Regulatory Strategies, UDI/GTINs, Product Development, Marketing & Sales, Operations and Supply Chain Management. Read More
Brigid Glass- QMS Expert
Brigid Glass is a Quality Management Systems consultant who resides in New Zealand. She is a lively and passionate trainer who specializes in coaching smaller medical device companies to build Quality Management Systems (QMS) for compliance with ISO 13485, ISO 14971, the 21 CFR 820 (FDA QSR), and other international regulatory requirements. Read More
Marcus Gould – CE Marking & EU Registration Expert
Marcus specializes in pre-market CE Marking applications and registration of medical devices in the EU. He also has extensive expert knowledge with regard to post-market interactions with Notified Bodies and Competent Authorities regarding vigilance reporting of adverse events. He holds a doctorate in biochemistry (microbiology) from the University of Oxford, holds both Chartered Biologist and Chartered Scientist status, and is a consultant editor for TOPRA’s monthly publication ‘Regulatory Rapporteur’. Read More
Lena R Huerlimann has 18 years QC/QA/RA experience in pharmaceuticals and medical devices. Her auditing expertise includes GMP/GLP/GCP environments, as well as ISO 13485/ISO 9001/ISO 15378 facilities. Read More
Dr. Allison Komiyama is the Principal consultant of AcKnowledge Regulatory Strategies. She is a former FDA reviewer with expertise in medical device and combination product submissions. While working at FDA in the Office of Device Evaluation, she acted as a lead reviewer and consult on 510k Premarket Notifications, Investigational Device Exemption (IDE) applications and Premarket approval (PMA) submissions. Her additional specialty was in biocompatibility requirements for implanted devices. She can help your company with a regulatory plan, and your FDA submissions. Read More
Jon Speer – Design Control Expert
Jon Speer is a medical device veteran with more than 16 years experience. Jon specializes in helping medical device start-up companies with design project management. His experience with start-ups gave him the idea to develop a software solution to help companies document Design Controls. Read More