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The document details pre-market submission requirements for Software as a Medical Device (SaMD) in key jurisdictions: the US, EU, Canada, Japan, Australia, China, Korea, and Singapore. It stresses the importance of mutual understanding between software developers and regulators and specifies the necessary documentation and processes for compliance.

Key components include:

  1. Software requirement specification
  2. Software lifecycle process
  3. Traceability analysis
  4. Defect management
  5. Change history

Additionally, it references guidance documents and regulations from other bodies and addresses non-SaMD specific requirements.

Source:https://www.ahwp.info/sites/default/files/GHWP%20Comment%20Submission%20Form%20%28ver%2020240909A%29_1.pdf

Region:Global

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