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Design control requirements of Part 820

Discussion in 'Medical Devices (21 CFR Part 820)' started by talent.acquiring, Feb 5, 2019.

  1. talent.acquiring

    talent.acquiring New Member

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    Can someone please describe these requirements and how they are relevant to a Software Quality Engineer?
     
  2. yodon

    yodon Active Member

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    Pretty broad question so the answer may be a little high-level.

    Design Controls in 21 CFR 820 (https://www.ecfr.gov/cgi-bin/text-i...27aa75df2d32&mc=true&node=pt21.8.820&rgn=div5) comprise design inputs, outputs, V&V, reviews, and change management. Clearly, each of those is relevant to software. Design inputs are your requirements (which should include risk controls to be implemented in software!). Design outputs are your architecture documents, design documents, etc. V&V include your software system tests and such. Reviews, in the standard, are more typical of "stage gate" reviews (e.g., a transition between requirements and design might include an overall review of the requirements for completeness, etc. - not necessarily an individual document review). Changes are how you control changes once your baseline is established.

    Another good source of information is IEC 62304. The FDA has recognized this as a consensus standard so complying with it will provide compliance with FDA requirements.

    Does that help or did you have more specific questions?
     

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