Greg Spar

Software and Design Consultant

Greg Spar is a Software & Design Consultant at DuVal & Associates, P.A., a law firm dedicated to counseling companies in the medical device, pharmaceutical, biotech, food, and nutritional supplement industries. He focuses on advising and supporting clients on software and hardware design requirements to comply with requirements for regulated industries.

Greg works extensively assisting clients with preparation, review, and guidance on software and design control related documentation including cybersecurity design, system and risk analysis to support marketing submissions and applications (FDA submissions including pre-submissions, 510(k)s, de novos, PMAs, European Design Dossiers and Technical Files, etc.). Greg brings over 20 years of experience in working with industry. He has extensive experience with neurological products including pain control, obesity treatments and drug delivery as well as cardiovascular product design.

Prior to joining DuVal & Associates, he provided software and design expertise at a variety of device companies including Medtronic, EnteroMedics, and ReShape Lifesciences. He brings extensive experience in hardware and software development, telemetry communications and protocols for wired and wireless systems, cybersecurity, troubleshooting, system analysis, risk analysis including FMEA, regression analysis, traceability analysis, specification and test plan development, report execution, development of design control SOPs, and management of commercial off-the-shelf software (COTS) and software of unknown providence (SOAP). Greg has been granted several US patents and industry awards, including a Security Industries Association (SIA) Standards Achievements Award for his work as Chair and Technical Editor of an SIA committee that developed an ANSI Standard related to security.

Helping clients be appropriately aggressive, yet compliant. TM