EU MDR Gap Analysis Tool
Thanks for your interest in the MDR Gap Analysis Tool!
As you are aware, the European medical device industry will undergo significant change as a result of the new medical device regulations. Companies not following the new rules will not be allowed to sell their medical products in the European Union.
In response, and in order to find any shortfall in your quality management system, Regulatory Globe has developed a FREE TOOL to help. There are 2 documents you can access: a gap analysis spreadsheet, and a Classification Rules checklist.
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