![]() These must be sufficiently robust to provide confidence to your ISO assessor that the clauses of the quality management standard are being rigorously complied with by your business. ![]() ![]() ISO 13485 certification provides confidence for interested parties in medical device quality conformity.Ĭonformity with and ultimately certification against ISO 13485:2016 includes the effective implementation of quality procedures and records including technical files. Class I medical devices are associated with the lowest level of risk while class III medical devices are associated with the highest level of risk. ISO 13485:2016 is the international quality management standard for medical devices.Ĭlass IIa, IIb, and III Medical device manufacturers who sell products within the UK and EU must apply controls as part of a formal ISO 13485 quality management system. ![]() Medical Device ISO 13485 Quality Systems Consultancy
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