Our team

Patrick L. Biggins is the Founder of Biggins Quality and a recognized leader in quality and manufacturing strategies for new medical device technology development. Prior to forming this company, Patrick provided leadership to many members of the medical device and pharmaceutical industries, from guiding start-up medical device companies to providing senior leadership at major medical device manufacturers. Using his 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. Patrick is a Senior Member ASQ, with over 27 years of medical device industry experience and 38 years of experience in the field of engineering. A full resume is available upon request.

Brice L. Biggins, Esq., CBA is the Managing Director of Biggins Quality. Brice's experience includes implantable devices, in vitro diagnostic devices, laboratory developed tests (LDTs), orthopedic devices and instruments, regulatory compliance, and product life cycle investigations. Brice has successfully led 510(k) submissions, including AINN responses and being the main point of contact for the FDA, and participated in PMA supplements for Class III medical devices. Prior to joining Biggins Quality, Brice assisted corporate clients by providing legal advice with respect to regulatory compliance, and operational and transactional matters. Brice is a BSI certified lead auditor for ISO 13485 (9001) and an ASQ Certified Biomedical Auditor (CBA). A full resume is available upon request. 

Katina V. Krasnec, PhD, is the Clinical Research Expert of Biggins Quality. Dr. Krasnec's experience includes database management, statistics, clinical study design and management, experimental and protocol design, and project management. Dr. Krasnec provides clientele with cutting edge expertise in CRISPR/Cas9 genome editing, large and small animal model studies, and bioinformatics. Prior to joining Biggins Quality, Dr. Krasnec provided expert research support to members of the private sector and multiple U.S. government agencies including National Institute of Health (National Institute of Aging and National Institute on Allergy and Infectious Disease), and U.S. Dept. of Agriculture. A full resume is available upon request.