MD Regulatory Blog
ISO 13485, EU MDR, FDA QMSR, IEC 62304 — practical guidance written by regulatory affairs experts.
Annex XVI MDR products are regulated more strictly than the medical devices they resemble, and most manufacturers find that out when a notified body rejects…
ISO 17664 exists because a reusable medical device is only as safe as the worst reprocessing cycle a hospital will ever run on it, and…
Combination products are the one category in which a manufacturer has to satisfy two regulatory cultures at once, and the United States and the European…
ISO 10555 is the standard every intravascular catheter file cites and the one most of them cite wrongly. The series is the undisputed state of…
ISO 80369 exists because the Luer connector is too good at its job. A single conical fitting that lets almost any syringe join almost any…
ISO 15223 is the reason a device label can say almost nothing in words and still say everything a regulator requires. Under MDR Annex I,…
IEC 60601-1 electrical safety compliance is not a single test you run at the end of development — it is a chain of decisions that…
ISO 20417 is the horizontal standard that decides what has to be on a medical device label, in its instructions for use and in its…
IEC 62366 is built on one uncomfortable idea: a patient can be seriously harmed while every component of the device performs exactly as specified. The…
Full conformity with ISO 22442 is the part of an animal-tissue file that nobody argues about, and it is not the part that decides whether…
MDCG 2019-11 is the guidance that decides two things about a piece of software: whether it is a device at all, and if so, which…
ISO 24971 is the document that explains how to do what ISO 14971 requires, and for in vitro diagnostic medical devices it carries something the…
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