MD Regulatory Blog
ISO 13485, EU MDR, FDA QMSR, IEC 62304 — practical guidance written by regulatory affairs experts.
Post-market surveillance is where the EU MDR departs most sharply from the Directive it replaced. Under the MDD, PMS was a general obligation with no…
Biocompatibility testing is one of the most fundamental requirements in medical device development. Any device that comes into contact with the human body — whether…
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…
The ISO 13485 CAPA procedure — covering corrective and preventive action — is consistently one of the most scrutinised elements of a medical device quality…
Software as a Medical Device is defined by the IMDRF as software intended for one or more medical purposes that performs those purposes without being…
The Clinical Evaluation Report is the most consequential document in an EU MDR technical file, and the one Notified Bodies most often find inadequate. It…
The internal audit is the most powerful tool a quality team has, and the one most often reduced to a formality. Done well, it finds…
EU MDR technical documentation requirements define the full scope of evidence that every medical device manufacturer must compile, maintain, and make available to demonstrate compliance…
The EU MDR transition deadlines are now in their final phase. The first hard date under the extended timeline — 26 May 2026, for Class…
Cybersecurity testing for medical devices has moved from recommended practice to submission requirement. The FDA expects security testing documentation in the premarket submission, and MDCG…
IEC 81001-5-1 cybersecurity for health software has become one of the most referenced standards in the medical device and digital health regulatory landscape. As connected…
ISO 13485 is the quality management system standard for medical devices, and since February 2026 it is also the legal basis for FDA quality system…
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