Regulatory Affairs

Regulatory Affairs

A key aspect of medical devices development is compliance to the various standards such as the EU Medical Device Directives as well as the new EU Medical Device Regulations. We ensure that your medical device complies with these statutory requirements and is awarded with a CE Mark so that you may register the products in your markets.

We will advise you if you require a complete compliance or if you would be able to depend on the regulatory compliances already achieved by the manufacturer or even use the quality approvals and CE Mark of the manufacturer. Each case has to be individually evaluated and advised.

A full regulatory dossier will be available for all products developed by NZ Medical.