Introduction to Medical Device Manufacturing

This is a one-day course for employees new to the medical device industry, or for individuals interested in entering the field. Participants will learn key components of medical device development and manufacturing, including an overview of the objectives and applications of current Good Manufacturing Practices (cGMP’s). In the context of regulatory compliance, additional topics include Good Documentation Practices, Product Design, Verification, Validation, and Risk Management. Consequences of Product Failures and related outcomes are also discussed, including CAPA, Recalls, Root Cause Analysis, and potential regulatory actions.