Dennis Shay
Global Medical Device / IVD Regulatory Affairs, Quality, and Clinical
- Role
- Founder and President at Myomo, Inc.
- Location
- Boston, MA, US
- LinkedIn followers
- 500 followers
About Dennis Shay
Dennis is a global leader in medical device and IVD regulatory affairs, quality, and…
Experience
Founder and President
Jul 2024 — Present · Medford, MA, US
When not working a full-time job, I provide consulting services for medical device Regulatory and Quality organizations from startups to large organizations requiring remediation.My areas of expertise are with all US and EU classifications of devices and IVDs, including cardiology (defibrillation), electromechanical, SaMD, AI, remote monitoring, IVDs (home and PoC), insulin pumps, digital health, combination, and implantable devices. I have extensive experience with FDA pre-subs, 510(k)s, de novos, PMAs, PMA supplements, Master Files, and eMDR. I have been through several successful full MDR and IVDR Stage 1 and 2 audits and have generated EU MDR/IVDR compliant technical documentation and declarations of conformity. I also have extensive experience with contract manufacturing, ISO 13485 QMS design and implementation, ISO 14971 risk management, process and equipment validation and qualification, design controls, and post market surveillance. I also provide interim leadership, team building, and career development coaching to build operational efficiency of quality and regulatory teams.
Education
Penn State University
Bachelor of Science (BS) with Honors
Penn State University
Doctor of Philosophy (Ph.D.)
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