QMSR coordinates with multiple regimes. (a) ISO 13485:2016 (NEEDS LICENSED COPY) - incorporated by reference + the substantive QMS content lives in this copyrighted ISO standard. (b) EU MDR (Regulation (EU) 2017/745) + EU IVDR (Regulation (EU) 2017/746) parallel medical-device + IVD regulations - dual-validated manufacturers face MDR Article 10 + IVDR Article 10 manufacturer obligations alongside QMSR + ISO 13485:2016; the EU regulatory pathway typically requires ISO 13485:2016 certification from a Notified Body (NB) as the primary QMS evidence + the QMSR maps similar requirements to FDA QMS evidence. (c) FDA Part 11 - electronic records + electronic signatures used in QMSR record-keeping per §820.35. (d) FDA Premarket Cybersecurity Guidance (2014 + 2018 + 2023 + 2024 updates) + Cures Act Section 524B - cybersecurity built into design controls + risk management for medical device software (SaMD + Software in a Medical Device); Software Bill of Materials (SBOM) for medical device software premarket submissions per 2024 FDA premarket cybersecurity guidance. (e) ISO 14971 (medical-device risk management) + ISO 14155 (clinical investigation) + ISO 11607 (packaging for terminally sterilized devices) + IEC 62366-1 (usability engineering) + IEC 62304 (medical device software lifecycle) + IEC 80001 (medical IT network risk management) - companion standards routinely incorporated by reference into QMSR-aligned QMS.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.