Choose Presafe for global market access

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.

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 Downloads

• Change Notification
• Certification Process
• Confidentiality
• MDD questionnaire
• IVD Questionnaire
• Quality System Checklist
• Essential Requirements Checklist MDD
• Essential Requirements Checklist IVD
• Checklist EC Declaration of Conformity
• Checklist EC Type Examination (Annex III)
• Checklist EC Design Examination (Annex II§4)
• Application incl. Terms and Conditions
• Use of CE mark

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