Patrick L. Biggins, Senior Member ASQ, is the founder and a recognized leader in quality and manufacturing strategies for new medical device technology development. Prior to forming this company, Patrick was a leader at various companies, from roles at start-up medical device companies to responsibilities as a senior leader at a major medical device manufacturer. From this broad experience across many types and classes of medical devices, Patrick assists clients from the early stage of a medical device’s concept through the entire life cycle of the device. Patrick has been responsible for the successful submissions of IDEs, PMAs and European technical files. A full resume is available upon request.
Brice L. Biggins, Esq., CBA, is the Managing Director of Biggins Quality. As a Certified Biomedical Auditor (CBA), Brice has expertise regarding 510(k) submissions for medical devices and PMA supplements for Class III medical devices, including implantable devices, orthopedic devices and instruments, regulatory compliance, and cradle to grave investigations. Prior to joining Biggins Quality, Brice assisted corporate clients by providing legal advice with respect to operational and transactional matters as in-house counsel. A full resume is available upon request.
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