Quality, Efficiency, and Regulatory Affairs Consultant
Tom Renner is an independent consultant who has worked in the medical device industry for 20 years. He has hands-on familiarity with most functions and departments of a successful medical device startup and has built and managed processes and teams for technical writing, software and hardware development, quality assurance, and regulatory affairs.
He has extensive experience with medical device software, quality system development (ISO 13485, ISO 14971), FDA 510(k) clearance, and CE mark under the Medical Device Directive (93/42/EEC). He’s an effective public speaker, teacher, copy editor, and troubleshooter with a strong foundation in physics, chemistry, biology, mathematics, and written language
Tom has a BS in Engineering & Applied Science from Caltech.