• Abbreviated 510(k) Technical File Template
    Abbreviated 510(k) Technical File Template
  • Annual Training Schedule
    Annual Training Schedule
  • Competency Matrix
    Competency Matrix
  • Quality Objectives
    Quality Objectives
  • Quality Policy
    Quality Policy
  • Traditional 510(k) Technical File Template
    Traditional 510(k) Technical File Template
  • Internal Audit checklist for ISO 13485:2016
    Internal Audit checklist for 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
  • 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
  • SaMD Regulatory Requirements Checklist for Registration in the USA
    SaMD Regulatory Requirements Checklist for Registration in the USA