This webinar will discuss the Q-Submission program, with includes Pre-Subs, Submission Issue Requests (SIRS), Study Risk Determinations, Informational Meetings, PMA 100-Day Meetings, and other meetings and uses for Q-Sub requests.
ISO 9001 is an internatioinal standard for Quality Management Systems for all business or industrial systems, and is used as such by companies worldwide.
This webinar will provide valuable guidance to regulated companies in development and implementation of Project Management Planning and Techniques with ChatGPT / AI assistance for new product development, regulatory compliance audit responses, proof of "progress against plan", and other activities requiring a planned documented rationale.
This webinar will provide valuable guidance to regulated companies in development and implementation of formal, defined, documented methods for analysis of product changes and when to file a new 510(k).