ISO 13485 Design Controls: Requirements and Design History File
The ISO 13485 design control requirements are where most small and medium medical device manufacturers fail their first certification audit. Clause 7.3 of ISO 13485:2016 governs…
MD Regulatory Blog
EU MDR 2017/745
EU MDR 2017/745
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EU MDR GSPR Checklist: How to Demonstrate General Safety and Performance Requirements
Every medical device placed on the EU market must demonstrate conformity with the General Safety and Performance Requirements set out in Annex I of Regulation…
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EU MDR Post-Market Surveillance : PMS Plan, PSUR and PMCF Requirements
EU MDR post-market surveillance is one of the most operationally demanding requirements of Regulation (EU) 2017/745 — and the area where the gap between what the…
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ISO 14971 Risk Management for Medical Devices: Complete Process Guide
ISO 14971 is the foundational international standard for risk management of medical devices. It specifies terminology, principles, and a comprehensive process for risk management of…
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EU MDR Clinical Evaluation Report: Requirements, Structure and Common Mistakes
The Clinical Evaluation Report is the single most consequential document in a medical device technical file under EU MDR 2017/745. It is also the document…
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EU MDR Technical Documentation Requirements: Complete Guide to Annex II and III
EU MDR Technical Documentation Requirements: Complete Guide to Annex II and III EU MDR technical documentation requirements define the full scope of evidence that every medical…
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EU MDR Transition Deadlines 2026, 2027 and 2028: The Complete Guide for Medical Device Manufacturers
Introduction EU MDR transition deadlines are now an immediate operational reality for every medical device manufacturer selling in the European Union. European medical device makers face…
