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MDQMS [ISO 13485:2016] Implementation

Implementation of Medical Device Quality Management System is evidence to show well-wishers and prospective buyers that your organization follows International standards for maintaining and improving the quality of the product on day by day basis.

For CE Marking, Notified Body Insists audit to be carried out as per MDD. To fulfill the regulatory requirements the manufacturer has to select the route of CE marking as per Annex 11 to Annex 1X of the directive.

Class I Medical Device without a measuring function and supplied in a non-sterile condition does NOT require the Notified Body as conformity to the International and European Standard EN ISO 13485 is voluntary.

Whereas, Class 11a, class 11b, class 111 Medical Device require the involvement of a Notified Body. Conformity to the International and European Standard EN ISO 13485 is mandatory nowadays.

For Better understanding refer the table below:

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