Overview of data sources
| Data source | Description | Quantity/Duration |
|---|---|---|
| Semi-structured interviews | Auditors, technical assessors, managers and consultants with AI and conformity-assessment experience | 17 interviews (60–90 min each) |
| Documentary material | EU MDR/IVDR texts, MedTech Europe and Team-NB reports, accreditation body statements | 12 documents |
| Observations | Conferences, panels and expert meetings on AI in conformity assessment | 5 events (1–2 days each) |
| Data source | Description | Quantity/Duration |
|---|---|---|
| Semi-structured interviews | Auditors, technical assessors, managers and consultants with AI and conformity-assessment experience | 17 interviews (60–90 min each) |
| Documentary material | EU MDR/IVDR texts, MedTech Europe and Team-NB reports, accreditation body statements | 12 documents |
| Observations | Conferences, panels and expert meetings on AI in conformity assessment | 5 events (1–2 days each) |
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