MD Regulatory Blog
ISO 13485, EU MDR, FDA QMSR, IEC 62304 — practical guidance written by regulatory affairs experts.
SOUP management under IEC 62304 is one of the most underestimated — and most frequently audited — aspects of medical device software compliance. Almost every…
IEC 62304 defines the life cycle processes for medical device software. It is the standard a Notified Body reaches for first when it opens a…
The benefit-risk determination is the conclusion the whole technical file exists to support. Every risk control, every clinical study, every piece of post-market data feeds…
GAMP 5 is the internationally recognised approach to validating computerised systems in regulated industries. GAMP stands for Good Automated Manufacturing Practice, and the guide is…
The sixth edition of ISO 10993-1 introduces updated requirements that affect both the biological evaluation process and the assessment of medical devices during development and…
The Medical Device Single Audit Program lets one audit of a quality management system satisfy five regulatory authorities: Australia’s TGA, Brazil’s ANVISA, Health Canada, Japan’s…
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…
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