Scott Lambert is an Engineering 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 hardware and software design to comply with requirements for regulated industries.
Scott assists clients with preparation, review, and guidance on design and software related documentation including standards compliance, system and product requirements, design implementation, test protocols and reports, traceability, 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.). Scott brings over 35 years of experience of medical device development. He has extensive experience with Class III implantable devices such as neurostimulation, diagnostic, and patient monitoring products as well as Class II devices including CPAPs, bilevel ventilators, electrosurgical instruments, and vital signs monitoring for home and hospital use.
In addition to supporting clients of Duval & Associates, PA., Scott has provided design and development expertise at a variety of device companies including Aequitron Medical, Nellcor-Puritan Bennett, Mallinckrodt, Tyco, Data Sciences, Transoma Medical, EnteroMedics, ReShape Lifesciences, Nuvectra, Olympus, and ShiraTronics. He brings extensive experience in hardware and software development, program management, system requirements and partitioning, product requirements, risk analysis including FMEA, design documentation, regression analysis, test plans and reports, requirements traceability, and development of design control SOPs. Scott earned his Bachelor of Science in Electrical Engineering from the University of Minnesota. He has been granted several US patents and has been trained as a Project Management Professional.