Annex XVI MDR : Common Specifications, Classes and Deadlines
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…
MD Regulatory Blog
Design Control
Design Control
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ISO 80369: Small-Bore Connectors and Misconnection Risk
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…
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IEC 60601-1 Electrical Safety: Clause 8 and the MOP Rules
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…
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IEC 62366: Usability Engineering Process, File and Evidence
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…
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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…
