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AAMI TIR105:2020 Risk management guidance for combination products, 2020
- AAMI TIR105:2020; Risk management guidance for combination products
- Title page
- AAMI Technical Information Report
- Copyright information
- Contents
- Committee representation
- Foreword
- Introduction
- 1 Scope [Go to Page]
- 2 Normative references
- 3 Terms and definitions
- 4 Risk management plan [Go to Page]
- 5 Risk assessment [Go to Page]
- 6 Risk control [Go to Page]
- 7 Risk management report
- 8 Risk review monitoring [Go to Page]
- Annex A (informative) Summary of requirements of ISO 14971, ICH Q9, and AAMI TIR48 [Go to Page]
- Annex B (informative) Combination product risk management utilizing a risk traceability summary
- Figure B.1—Risk assessment trace matrix
- Figure B.2—Tools and techniques used during the design process to perform risk analysis
- Figure B.3—Streamlined risk management trace matrix
- Table B.1—Risk management traceability
- Table B.2—Risk management traceability (page 2)
- Bibliography [Go to Page]
