Good Manufacturing Practices (GMP): User Requirement Specifications

FDA Design Control Guidance for Medical Device Manufacturers

US FDA 21 CFR 820.30 Design Control Requirements.

At the design stage, an outline of the design control process should be actualized. Here is a diagram describing the Design and Development Planning.

Medical Device Design and Development Planning

Design Input

There are several parameters which contribute to the design input:

  • Performance
  • Safety
  • Business Economics
  • Risk Management
  • Regulatory Requirements
  • Stakeholder feedback (Clinicians, patients, hospitals etc.)

Design Output

  • The fabricated device
  • User Manual
  • Risk Analysis Study
  • Other technical documentation

Design validation follows successful design verification. The design validation takes into account the user needs.


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