The FDA regulations for medical devices have been in place for over 35 years, but are changing more rapidly now than ever before. These days FDA expects quality to be pervasive throughout an organization and not relegated to simple manufacturing process controls. The Agency is also revising the 510(k) regulatory submission process, a fundamental pathway for new product clearances. It is imperative that device developers, manufacturers and distributors understand these changing regulations and implement the necessary controls and processes. This presentation will provide a high level overview of the FDA regulatory process, from testing through submission and clearance/approval, as well as the quality system requirements, both under the regulations and from a best business practices perspective.
- FDA Medical Device Classification and Submission Process
- FDA Quality System Requirements – Pre and Post Marketing
- Regulatory Harmonization in a Global Economy
Bill Greenrose is a Director in Deloitte & Touche’s Governance Regulatory and Risk Strategies practice. He has over 30 years of experience in FDA regulated and Life Science industries in the areas of regulatory, clinical, quality assurance, quality control, laboratory, R&D, manufacturing, core lab, compliance and corporate/operations.
With his broad and deep knowledge and experience, Bill assists clients globally in developing strategies concerning regulatory approach and submissions (e.g. pre-IDE, IDE, 510(k) PMA, CE Mark, Technical File), quality systems (e.g. QSR, GxP, ISO 13485, ISO 9001), regulatory compliance (proactive and reactive, e.g. Warning Letter/FDA 483 response), auditing and training in a highly regulated environment. Bill has consulted for various national and international pharmaceutical, medical device, and biotechnology companies and is internationally recognized for his subject matter knowledge concerning regulatory compliance, quality systems, and computerized systems validation (e.g. 21 CFR 11). Bill has presented around the world on regulatory strategy and compliance and has trained Korean FDA investigators on FDA inspection techniques.
Breakfast will be provided.