DNV Nemko Presafe A/S (Presafe) is a global testing and certification company specialized in medical devices. We provide worldwide market access for our customers´ products through a global presence with efficient and reliable testing and certification services based on EU directives and international safety and quality standards.
Presafe in Norway and its subsidiary DGM Denmark AS offer certification and training services based on ISO13485, ISO9001, Medical Device Directive (MDD), In-Vitro-Diagnostics Device Directive and the Canadian Medical Device Conformity Assessment System (CMDCAS). DGM Denmark AS is in addition is a recognized partner of the Taiwan Technical Cooperation Program.
Manufacturers face increasing challenges to satisfy customer and certification requirements. In both Europe and the US, manufacturers experience that review processes are becoming more complicated and less predictable. Some countries have more comprehensive rules than others. Presafe understands that time to market and the ability to manage increasingly complex regulatory requirements are key concerns for manufacturers today.
That´s why we emphasize that Presafe builds its 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 solutions. Presafe has resources in all major markets with expertise in standards and regulations in the local language as well as in English, able to deliver according to your certification needs.
Presafe provides global market access by testing and certifying the safety and quality of products and systems according to international safety and quality standards and regulations.
Presafe is a joint venture between the global certification bodies DNV Business Assurance and Nemko AS (www.nemko.com). The combined presence of our parent companies includes offices in 48 countries, a network of 2200 industry professionals and a broad range of testing facilities. In addition, DGM Denmark A/S joined Presafe in 2012, further strengthening our service offering for medical devices.