MDQMS Implementation

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

For CE Marking, Notified Body Insists audit to be carried out as per MDD. To full fill the Directive requirement manufactures 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 non-sterile condition does NOT require the involvement of a Notified Body. 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 now days.

For Better understanding refer the table below:

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