Templates and Checklists

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  • Checklist for Medical Device file as per clause 4.2.3 of ISO 13485:2016
    Checklist for Medical Device file as per clause 4.2.3 of ISO 13485:2016
  • Checklist for Device Master Record as per 21 CFR 820.181 Requirements
    Checklist for Device Master Record as per 21 CFR 820.181 Requirements
  • SaMD Regulatory Requirements Checklist for Registration in the USA
    SaMD Regulatory Requirements Checklist for Registration in the USA
  • Abbreviated 510(k) Technical File Template
    Abbreviated 510(k) Technical File Template
  • Master List of Source Document for Periodic Safety Update Report (PSUR)
    Master Checklist of Source Documents for Periodic Safety Update Report (PSUR)
  • Competency Matrix
    Competency Matrix
  • Annual Training Schedule
    Annual Training Schedule
  • Internal Audit checklist for ISO 13485:2016
    Internal Audit checklist for ISO 13485:2016
  • Traditional 510(k) Technical File Template
    Traditional 510(k) Technical File Template
  • Quality Policy
    Quality Policy