Summary of the main themes and subthemes
| Main themes | Subthemes | Linkage to research questions |
|---|---|---|
| 4.1: The need for ISO 14971:2007 revision | 4.1.1: Transitioning to ISO 14971:2019 compliance | RQ1 |
| 4.1.2: Regulatory scrutiny and compliance expectations | ||
| 4.2: Challenges in implementing ISO 14971:2019 | 4.2.1: Feedback of information from Production and Post-Production Activities | RQ1 |
| 4.2.2: Benefit–Risk Analysis | ||
| 4.2.3: Risk Acceptability Criteria | ||
| 4.2.4: Disclosure of Residual Risks | ||
| 4.2.5: Reasonably Foreseeable Misuse | ||
| 4.2.6: Risk Reduction as far as possible | ||
| 4.2.7: Risk Analysis | ||
| 4.2.8: Risk Management Policy | ||
| 4.2.9: EN ISO:14,971+A11:2021 views | ||
| 4.3: Global Regulatory Trends in Benefit–Risk Analysis | 1. Understanding and interpretation of the term “benefit–risk ratio.” | RQ1 |
| 4.4: Enhancing implementation of ISO 14971: Stakeholder Recommendations | 4.4.1: Process of completing a Benefit–Risk Analysis | RQ2 |
| 4.4.2: Cybersecurity Risks | ||
| 4.4.3: ISO 14971 as a normative reference | ||
| 4.4.4: Confusing language of ISO 14971 | ||
| 4.4.5: Z Annexes of EN ISO 14971:2019+A11:2021 | ||
| 4.4.6: Devices with Software and Emerging Technology | ||
| 4.4.7: Mandate the use of P1 and P2 and Hazard Analysis | ||
| 4.4.8: Risk Management Systems | ||
| 4.4.9: Flexibility of the Risk Management Process |
| Main themes | Subthemes | Linkage to research questions |
|---|---|---|
| 4.1: The need for ISO 14971:2007 revision | 4.1.1: Transitioning to ISO 14971:2019 compliance | RQ1 |
| 4.1.2: Regulatory scrutiny and compliance expectations | ||
| 4.2: Challenges in implementing ISO 14971:2019 | 4.2.1: Feedback of information from Production and Post-Production Activities | RQ1 |
| 4.2.2: Benefit–Risk Analysis | ||
| 4.2.3: Risk Acceptability Criteria | ||
| 4.2.4: Disclosure of Residual Risks | ||
| 4.2.5: Reasonably Foreseeable Misuse | ||
| 4.2.6: Risk Reduction as far as possible | ||
| 4.2.7: Risk Analysis | ||
| 4.2.8: Risk Management Policy | ||
| 4.2.9: EN ISO:14,971+A11:2021 views | ||
| 4.3: Global Regulatory Trends in Benefit–Risk Analysis | 1. Understanding and interpretation of the term “benefit–risk ratio.” | RQ1 |
| 4.4: Enhancing implementation of ISO 14971: Stakeholder Recommendations | 4.4.1: Process of completing a Benefit–Risk Analysis | RQ2 |
| 4.4.2: Cybersecurity Risks | ||
| 4.4.3: ISO 14971 as a normative reference | ||
| 4.4.4: Confusing language of ISO 14971 | ||
| 4.4.5: Z Annexes of EN ISO 14971:2019+A11:2021 | ||
| 4.4.6: Devices with Software and Emerging Technology | ||
| 4.4.7: Mandate the use of P1 and P2 and Hazard Analysis | ||
| 4.4.8: Risk Management Systems | ||
| 4.4.9: Flexibility of the Risk Management Process |
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