MD Regulatory Blog
ISO 13485, EU MDR, FDA QMSR, IEC 62304 — practical guidance written by regulatory affairs experts.
EUDAMED Registration: Step-by-Step Guide for Medical Device Manufacturers Understanding the EUDAMED registration requirements for medical devices is now urgent rather than optional. On 27 November 2025 the
A medical device cybersecurity risk assessment is no longer a documentation exercise that supports a submission — it is now a condition of market access. Since the
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 governs
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
Introduction 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 term
SO 13485 supplier management is one of the most operationally complex requirements of the standard — and one of the most consistently found-deficient in Notified Body
The FDA De Novo pathway is one of the most strategically important — and most misunderstood — routes to US market authorization for medical devices. It exists
EU MDR post-market surveillance is one of the most operationally demanding requirements of Regulation (EU) 2017/745 — and the area where the gap between what the
Biocompatibility testing is one of the most fundamental requirements in medical device development. Any device that comes into contact with the human body — whether it
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 Actions — is consistently one of the most scrutinized elements of a medical device quality management system.
Software as a Medical Device (SaMD) is one of the fastest-growing and most regulated categories in the entire medical device industry. From AI-powered diagnostic algorithms to
Welcome offer
Audit-ready documentation, at a welcome price
−20%
Join the MD Regulatory list and get 20% off your first kit — ISO 13485, MDSAP, EU MDR Clinical, and the full catalog.
Check your inbox.
We just sent your 20% welcome code. It should arrive within a minute — check spam if you don't see it.
Added to cart
Check out our shop to see what's available