MDQMS Implementations

Note: As we are accredited by ASCB-(E)-UK for ISO 9001-2008 and ISO 13485-2003 Certification, we cannot offer consultancy of implementation of ISO 9001-2008 and ISO 13485-2003 to the companies which are certified by us.

The following services are related to product certification activity.

The selection of conformity assessment body and selection of conformity assessment procedure is the liberty of the manufacturer of the medical device, AVS certification services help manufacturers to identify most suitable conformity assessment procedure and most suitable conformity assessment body for their products or medical devices.

For the conformity assessment procedure of medical devices, directive identified the standard for conformity assessment of the medical device, we have to refer the guidelines of the directive and the applicable standard and implemented the system in our organization.

Implementation of Medical Device Quality Management System is an evidence to show interested parties 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 II to Annex IX 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. In those cases, on the request of the manufacturer, the certification can be possible with the help of a product certification bodies which are accredited by an accreditation board for ISO 1765 scheme, the certification carry weightage in the international market and which indicate that an accredited certification body has certified the product. The criteria can be used as applicable directives, as in case of medical device directive, MDD 93/42/EEC is applicable medical device directive for different kind of medical devices.

Whereas, Class IIa, class IIb, class III Medical Device require the involvement of a Notified Body. ​

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Warje, Pune- 411058

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Telephone :- +91 - 9881946595

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