About the course

Includes: - SYS-008, Design Control Procedure - Webinar and Slides - 2024 Testing Plan Template - 18011 Final Test Report Guidance - FRM-011 v0.1: Design Transfer Checklist - FRM-018: Design Review Meeting Minutes - FRM-019 v0.6: Design Requirements Trace Matrix - FRM-024 v0.1: Design Input Form - FRM-060 v0.1: Use Specification Form - Overview of Regulatory Process, Medical Device Development & Quality System Planning for Start-ups - TMP-021: Design/Risk Management Plan - TMP-022 v0.1: Product Requirements Template - TMP-023 v0.1: User Needs Template - TMP-024 v0.1: Design Inputs Template - TMP-025 v0.1: Software Verification Protocol Template - TMP-026 v0.1: Software Verification Report Template - TMP-027 v0.2: Risk Management Report Template - TMP-065 v0.1: Draft Benchtop Performance Testing Protocol Template (if applicable) - TMP-066 v0.1: Draft Benchtop Performance Testing Report Template

Curriculum

2 Chapters · 20 Lessons

  1. 1
    1. (Included in full purchase)

      SYS-008: Design Control Procedure Webinar

    2. (Included in full purchase)

      SYS-008: Design Control Procedure (Slides)

  2. 2
    1. (Included in full purchase)

      SYS-008 v0.16 Design Control Procedure

    2. (Included in full purchase)

      2024 Testing Plan Template

    3. (Included in full purchase)

      18011 Final Test Report Guidance

    4. (Included in full purchase)

      FRM-011 v0.1: Design Transfer Checklist

    5. (Included in full purchase)

      FRM-018: Design Review Meeting Minutes

    6. (Included in full purchase)

      FRM-019 v0.6: Design Requirements Trace Matrix

    7. (Included in full purchase)

      FRM-024 v0.1: Design Input Form

    8. (Included in full purchase)

      FRM-060 v0.1: Use Specification Form

    9. (Included in full purchase)

      Overview of Regulatory Process, Medical Device Development & Quality System Planning for Start-ups

    10. (Included in full purchase)

      TMP-021: Design/Risk Management Plan

    11. (Included in full purchase)

      TMP-022 v0.1: Product Requirements Template

    12. (Included in full purchase)

      TMP-023 v0.1: User Needs Template

    13. (Included in full purchase)

      TMP-024 v0.1: Design Inputs Template

    14. (Included in full purchase)

      TMP-025 v0.1: Software Verification Protocol Template

    15. (Included in full purchase)

      TMP-026 v0.1: Software Verification Report Template

    16. (Included in full purchase)

      TMP-027 v0.2: Risk Management Report Template

    17. (Included in full purchase)

      TMP-065 v0.1: Draft Benchtop Performance Testing Protocol Template (if applicable)

    18. (Included in full purchase)

      TMP-066 v0.1: Draft Benchtop Performance Testing Report Template

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