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Developing a new medical device for commercialization is a complex process. The FDA has guidelines that provide a framework for designing and manufacturing medical devices.

This course will provide a detailed and practical overview of the design control process for medical device design and development. The course will cover design control under the FDA Quality System Regulation (21CFR820.30) and international Standard ISO 13485 for Quality Management Systems, in addition to the practical application in the design and development of electronic hardware, software, mechanical elements and labels. The course will also cover related aspects of associated Standards and Regulations such as Risk Management (ISO 14971), Usability (IEC 62366-1) and Software lifecycle (IEC 62304).

Topics Include:

  • Initial Design Control Process
  • Design Output Process
  • Verification and Validation
  • Design Transfer
  • Tagging, Tracing, Packaging and labeling
  • Risk Analysis

Practical Skill Development:

  • Understand the overall Design Control process
  • Understand the (10) elements of Design Control
  • Know how to apply each element of Design Control to the most common design disciplines
  • Know how to do Design Risk Analysis
  • Know how to do tracing between Risk Analysis, Design Input, Design Output, Design Verification and Design Validation
  • Know practical methods for Design Transfer and Design Review

Course Number: BIOL-40324
Credit: 3.00 unit(s)
Related Certificate Programs: Regulatory Affairs for Medical Devices

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