3/2/2024 0 Comments Din en iso 134852016 pdf![]() ![]() This no longer exclusively applies to development.Ī new term, namely the medical device family, allows for providing evidence not only on the level of a product, but also on the level of a medical device family. The demand of meeting regulatory requirements was already existent in Chapter 7.1. It is also explicitly included that regulatory requirements shall additionally be regarded as well as risk management. There must not be a black hole within the value-added chain. The new standard specifies that it explicitly also applies to outsourced processes. However, a variety of small changes even affecting chapter structure makes it necessary to deal with this latest version of the standard intensely. ![]() First off: ISO 13485:2016 is an evolution of the previous versions having barely been altered since ISO13485:2003 – not a revolution.
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