Design Controls for Medical Devices

Design Controls for Medical Devices - 21 CFR820.30

Design Controls for Medical Devices is a brief online course/webinar that gives a fast introduction to 21 CFR Part 820 Section 30, which is part of the US Code of Federal Regulations (CFR) that governs medical device development. As a “quick hit” induction to the subject, this course works wonderfully for getting new trainees to hit the ground running. The content for this course is already included in the Medical Device Development course, but for those who just desire this subject without the rest of the topics, Design Controls for Medical Devices only covers that area.

Design Controls for Medical Devices Course Objectives:

  • Learn the definition and basis for Design Controls
  • Understand how design controls are applied to medical device development
  • Become familiar with the contents of a Design History File (DHF)
  • Gain understanding for the process flows of Design Verification and Design Validation
  • Understand and summarize the nine parts of 21 CFR 820.30

Who should take this course?

  • Engineers and device team members new to their jobs
  • Team members that require proof of training in Design Controls (certificate awarded at end of course)
  • Experienced device professionals looking to brush up on regulations
  • Students at Universities looking to get a head start on learning for their new careers

Design Controls for Medical Devices Course Outline:

  • Introduction to Design Controls – 21CFR820.30 Parts and Definitions
  • The Design History File
  • Design Planning, Input, and Output
  • Design Verification
  • Design Validation
  • Design Transfer, Design Review, and Design Change

What you get:

  • Unlimited time access to 6 recorded online lectures (~ 1 hr of content)
  • Access to a medical device forum for discussing/asking questions to the instructor
  • Free updates to course material

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