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Regulatory Affairs
The technical requirements for medical devices are very similar around the world, being based on the national variants
of the IEC 60601 series of standards.
The medical device industry is, however, highly regulated. There are both technical and other requirements that must be
fulfilled before a medical device can be put on the market in any particular country.
Although 601help's main purpose is to assist in the understanding of of IEC 60601-1, the product safety standard, we also give a brief outline of
the FDA's regulatory requirements (USA), as well as the requirements for compliance with the Medical Devices Regulations (2017/745) (European Union).
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