Introduction to Medical Device Manufacturing



This is a one-day course for employees new to the medical device industry, or anyone interested in entering the field. Participants will learn key components of medical device development and manufacturing, with a focus on the objectives and applications of current Good Manufacturing Practices (cGMPs).  In the context of regulatory compliance, additional topics include 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.


  • Describe and identify the tools and processes specific to the medical device industry
  • Recall the cGMP and GDP parameters for medical device manufacturing
  • Identify design controls, risk management, validation, regulatory affairs, and FDA oversight for medical device companies
  • Describe consequences of product failures and related outcomes, including CAPA, Recall, and Root Cause Analysis
This course is currently not scheduled.  Contact us to request a date that works for you!

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Course Features

  • Lectures 0
  • Hands-On Training 0
  • Duration 8 hours
  • Skill level All Levels
  • Wet Lab No
  • Max Students 24
  • Assessments Yes