MD Regulatory Blog
ISO 13485, EU MDR, FDA QMSR, IEC 62304 — practical guidance written by regulatory affairs experts.
Annex II of Regulation (EU) 2017/745 defines the structure of the technical documentation every medical device manufacturer must compile. It is short — six sections…
EN 18286 is the point at which the AI Act stops being a policy document and becomes something a notified body can sit down and…
AI medical device regulation is now the single most confusing area of medtech compliance in Europe, and the confusion is structural rather than technical. A…
ANVISA registration is where confident manufacturers discover that a CE certificate is not a passport. The file that satisfied your Notified Body — the same…
An SBOM for medical device software is no longer a nice-to-have: for any device that meets the FDA’s definition of a cyber device, a machine-readable…
Understanding the EUDAMED registration requirements for medical devices is now urgent rather than optional. On 27 November 2025 the European Commission published Commission Decision (EU)…
A medical device cybersecurity risk assessment is no longer a documentation exercise that supports a submission — it is now a condition of market access.…
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…
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…
The title of this article reflects how the industry talks, not how the standards define the terms. IEC 62304 software verification validation is the search…
ISO 13485 supplier management is one of the most operationally complex requirements of the standard — and one of the most consistently found-deficient in Notified…
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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