Thank you Monir, for the informative video! I work for a european medical device manufacturer that only produces Class I devices. I've looked into getting MDSAP certified as we are already selling on the australian market and are looking into the States and Canada and are ISO 13485 certified. What I found while doing research however is that class I is usually exempt from audits. Is there a benefit for us to get MDSAP certified? MDSAP doesn't affect the process registering to market, correct? Or does it make it any easier?
@EasyMedicalDevice
2 жыл бұрын
Hi Marten, thanks for your message. Class I are usually self certified but the manufacturers need to have a quality management system. It is not mandatory to be certified but recommended. What is important to understand is that MDSAP is used mainly to avoid audits from the different countries, and use this as a single audit. But it is really rare that a country will initiate an audit for a class I device unless there is a problem on the market. So this is really a company strategy. For Canada, MDSAP is mandatory but I need to check if the rules are different for class I.
@martens4899
2 жыл бұрын
@@EasyMedicalDevice I understand. Just checked the rules and indeed for Canada MDSAP is not mandatory for Class I device manufacturers. Thank you for your reply.
@gerritaylor2660
6 ай бұрын
how do I get a copy of MDSAP Audit approach document
@EasyMedicalDevice
6 ай бұрын
The official copy is on the FDA website. Just write on google MDSAP Audit Approach PDF
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