![]() ![]() The aim of this is to ensure that manufacturers create (and maintain) all the documents required to demonstrate compliance with the regulatory requirements. ![]() ISO 13485 has required a medical device file since the 2016 edition. The medical device file: what ISO 13485 aims for and demands Is one of the three files required by the FDA (DMR, DHF, DHR) the same as the medical device file? It's time for a comparison to end unnecessary discussions within your team and with auditors. A lot of many manufacturers think that the medical device file is the same as the technical documentation required by the MDR or IVDR. ![]() ISO 13485 requires a medical device file for each medical device type or medical device group. The Medical Device File: What You Don’t Have to Include in This File
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