Medical Devices

Presafe Denmark A/S offers global market access with certification services according to the European medical device directive, ISO13485 standard, IVD directive, the Canadian medical device regulations and the Taiwan Technical Cooperation Program (TCP).

Presafe Denmark A/S is appointed by the Ministry of Health, Denmark as Notified Body no. 0543 and is also a member of the European Association of Notified Bodies for Medical Devices. 

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.

We work closely with our customers to properly understand their business needs, always searching for the optimal certification solution. With Presafe, you can enjoy an extensive reach and service offering, reduced time to market, and foremost a trusted partner!