EU MDR 2017/745 | FDA | MDR
ISO 10555 : Intravascular Catheter Standards for MDR and FDA
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…
MD Regulatory Blog
FDA
FDA
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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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ISO 15223: The Symbols Standard for Medical Device Labels
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,…
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FDA De Novo Pathway: When to Use It and How to Submit
The FDA De Novo pathway is one of the most strategically important — and most misunderstood — routes to US market authorization for medical devices.…
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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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Hidden Rules of 510k: What FDA Really Expects
The 510(k) is the most common route to the US market for medical devices. Named after Section 510(k) of the Federal Food, Drug, and Cosmetic…
