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This resource is the official English version of EU Decision No 768/2008/EC, one of the core documents of the EU’s

ISO 15223-1 “Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part 1:

This resource discusses the regulatory requirements for e-cigarette products under the EU Medical Device Regulation (MDR, Regulation (EU) 2017/745), and

This resource is the “Guidelines for Registration Review of Radiofrequency Beauty Equipment” issued by the Center for Medical Device Evaluation

This resource is the version of US Title 21 of the Code of Federal Regulations, Part 820 (21 CFR Part

This resource is the English version of the EUDAMED (European Database on Medical Devices) User Guide for Economic Operators published

ISO 10993-1 “Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process” is the

This resource is the guideline on review of human factors (usability) design of medical devices issued by the Center for

This resource is the official English version of the EU Regulation on market surveillance and compliance of products (Regulation (EU)

EN ISO 15223-1:2016 is the 2016 edition of the medical device labelling symbols standard as adopted in the EU. This