How MoniDoseQMS maps to ISO 13485, EU MDR, and FDA QMSR

When a manufacturer says a system is compliant, the honest question is: compliant with which requirements, and how? Standards like ISO 13485, EU MDR 2017/745, and the FDA Quality Management System Regulation are made of specific clauses, each demanding specific evidence. MoniDoseQMS is designed so that each requirement has a clear home. Here is how the mapping works in practice.

ISO 13485:2016 — the backbone

• §4.2 Documentation requirements → Document Management Hub, document control, and record archival
• §7.3 Design and development → Design Projects, design inputs and outputs, verification and validation
• §7.4 Purchasing → Supplier management, supplier scorecards, and receiving inspection
• §8.2.1 Feedback and §8.2.2 Complaint handling → Complaint handling and post-market surveillance
• §8.3 Control of nonconforming product → Non-conformance reports and deviations
• §8.5 Improvement → CAPA and preventive actions

EU MDR 2017/745 — placing and keeping a device on the market

• Annex II/III Technical documentation → Technical documentation and device master records
• Article 10 General obligations of manufacturers → the QMS as a whole, risk management, and clinical evaluation
• Articles 83-86 Post-market surveillance → PMS, PMS evaluations, and PSUR
• Articles 87-92 Vigilance → adverse event reporting, field safety notices, and recall management
• UDI and EUDAMED obligations → UDI records and EUDAMED data kept ready for submission

FDA QMSR — harmonised with ISO 13485

The FDA's Quality Management System Regulation (QMSR, 21 CFR Part 820) aligns United States requirements with ISO 13485 by incorporating ISO 13485:2016 by reference (in force since 2 February 2026), so the same design and development, production, CAPA and management review records can serve both. MoniDoseQMS keeps them in one system rather than maintaining two parallel sets of evidence.

21 CFR Part 11 — electronic records and signatures

Part 11 governs how electronic records and signatures are trusted. In MoniDoseQMS that means electronic signatures with password re-authentication and a clear signing meaning, access controls, and a tamper-evident, hash-chained audit trail. Part 11 compliance depends on how a regulated company validates and uses the system, and some items are still open on our side — covered in its own article.

Compliance is traceability you can show an auditor in minutes, not a binder you assemble in a panic the week before.