Medical Devices

Choose Presafe for global market access with testing and certification services according to the European medical device directive, ISO13485 standard, IVD directive, the Canadian medical device regulations and more.

Presafe and its subsidiary Presafe Denmark are both members of the European Association of Notified Bodies for Medical Devices. Together with our parent companies DNV GL Business and Nemko, we are pleased to service customers in 48 countries around the world, with 25 offices specifically delivering services for CE-marking of medical equipment.

Presafe is authorized to offer services on behalf of the owners until the company has achieved its own notifications.

In both Europe and the US, medical device companies experience that review processes are becoming more complicated and less predictable. Presafe provides global market access by ensuring the safety and quality of our customers´ products and systems according to relevant standards and regulations. We at Presafe understand that manufacturers are facing increasing challenges to satisfy certification requirements.

That´s why we emphasize that we build our services on trust, credibility and a long-standing industry position. Tougher safety and quality standards mean tougher requirements on those who test and assess. At Presafe, we pride ourselves in an uncompromising approach towards ensuring the safety and performance in our customers´ products and systems.

Medical News

Relocation Announcement

DNV GL Nemko Presafe AS moves to new location.
We are pleased to announce Presafe is moving to new...

IAF MD 9:2011 and the Impact on Audit Duration for Medical Device Manufacturers

The International Accreditation Forum (IAF) has issued a new Mandatory Document for the Application of ISO...

Extension to DGM Denmark A/S' accreditation

DGM Denmark A/S has obtained an extension to its existing accreditation according to 17021:2011 and can...

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