Good Manufacturing Practices (GMP): User Requirement Specifications

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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.

About Post Author

SurajPanigrahi

I started this blog for my love of writing and disseminating my views on things that excited me. I don't have a clear direction with this blog. However, you can find content mostly related to higher education, career development, MedTech, finance, and budget travel hacks. Background: After graduating in Mechanical Engineering from IIT (BHU) Varanasi, India, I pursued a dual degree Master's program in Europe (MS in Biomedical Engineering at RWTH Aachen, Germany and MS in Bioengineering at Trinity College Dublin, Ireland). I am currently working as a 'Manufacturing Engineer' in a MedTech company in Ireland.
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