![]() ![]() ISO 13485 is a mandatory requirement for CE Certification, after technical file approval the notification body will conduct an onsite audit to assess the level of ISO 13485 implementation. Any organization having the scope of manufacturing, design or servicing of medical device can implement ISO 13485. ![]() The latest version of the standard is ISO 13485 : 2016. ISO 13485 is an internationally accepted quality system standard for medical device industry.
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