Interview questions
| Number | Question | Sources in literature |
|---|---|---|
| 1 | What were the reasons for the revision of ISO 14971:2007 and the associated Technical Report? | Krenc (2018), Nolan and McDermott (2025) |
| 2 | How did your organization or MedTech companies you may have consulted with plan for compliance with the 2019 version of ISO 14971? | McDermott and Kearney (2024) |
| 3 | If your organization has not yet implemented the 2019 version of the standard, what compliance timelines are you working to? | Krenc (2018) |
| 4 | Have you experienced regulatory agencies (e.g. notified bodies, FDA, and competent authorities) questioning the compliance status with ISO 14971:2019 since its publication during surveillance audits or otherwise? | Caines et al. (2015), Elahi (2021), José (2017) |
| 5 | In your opinion, what are the top three areas of change in the 2019 version of ISO 14971 that have presented challenges for your organization or MedTech companies? | Elahi (2016), Niles (2015), Kearney and McDermott (2023a) |
| 6 | In your opinion, what potential challenges do you see device manufacturers facing, if any, to address compliance with EN ISO 14971:2019/A11:2021? | Elahi (2016), Niles (2015), Lafferty (2020) |
| 7 | In your opinion, why is there an increased focus on benefit–risk analysis in the 2019 version of ISO 14971? | Bills (2021a), Nolan and McDermott (2025) |
| 8 | The term “benefit–risk ratio” is referred to eight times in the EU MDR Regulation 2017/745 and on one occasion as part of ISO 14971:2019. How has your organization or MedTech companies defined/interpreted this term, i.e. from a quantitative or qualitative perspective? | Bills (2021a), Krenc (2018), Stern et al. (2020), Lafferty (2021) |
| 9 | What opportunities exist in the future for revisions to ISO 14971? | Stern et al. (2020), Nolan and McDermott (2025) |
| Number | Question | Sources in literature |
|---|---|---|
| 1 | What were the reasons for the revision of ISO 14971:2007 and the associated Technical Report? | |
| 2 | How did your organization or MedTech companies you may have consulted with plan for compliance with the 2019 version of ISO 14971? | |
| 3 | If your organization has not yet implemented the 2019 version of the standard, what compliance timelines are you working to? | |
| 4 | Have you experienced regulatory agencies (e.g. notified bodies, FDA, and competent authorities) questioning the compliance status with ISO 14971:2019 since its publication during surveillance audits or otherwise? | |
| 5 | In your opinion, what are the top three areas of change in the 2019 version of ISO 14971 that have presented challenges for your organization or MedTech companies? | |
| 6 | In your opinion, what potential challenges do you see device manufacturers facing, if any, to address compliance with EN ISO 14971:2019/A11:2021? | |
| 7 | In your opinion, why is there an increased focus on benefit–risk analysis in the 2019 version of ISO 14971? | |
| 8 | The term “benefit–risk ratio” is referred to eight times in the EU MDR Regulation 2017/745 and on one occasion as part of ISO 14971:2019. How has your organization or MedTech companies defined/interpreted this term, i.e. from a quantitative or qualitative perspective? | |
| 9 | What opportunities exist in the future for revisions to ISO 14971? |
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