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DNV NEMKO Presafe - Global Testing & Certification Services for Medical Devices.

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ABOUT
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.
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DNV NEMKO Presafe - About

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.

Offering certification and training services based

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.

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: Testing and certifying the safety and quality of products and systems

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.

Contact

info@presafe.com
Presafe Norway tel: +47 67578800
DGM Denmark tel: +45 39454999
www.presafe.com

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Top Products from DNV NEMKO Presafe

Product and Services

Presafe´s team of experienced compliance specialists and auditors offers you a quick and cost-effective route to global markets, along all the steps in your production, from pre-evaluation through to testing and training.

Presafe´s extensive services range from design review of high risk medical devices to approval of class Is or Im medical devices according to the medical devices directive 93/42/EEC as amended, the in vitro diagnostic directive 98/79/EC , INMETRO, CAMDCAS, as well as certification of management systems according to ISO 13485 and ISO 9001: Testing of…
Quick Contact DNV NEMKO Presafe



Quick Contact DNV NEMKO Presafe



DNV Nemko Presafe acquires DGM

By acquiring DGM, Presafe will significantly strengthen its position in the area of certification services for the medical device industry...
21st December 2012

DNV Business Assurance and Nemko join forces to establish DNV Nemko Presafe

The two global certification bodies DNV Business Assurance and Nemko announce the merger of their certification and testing operations for...
21st December 2012
Quick Contact DNV NEMKO Presafe





Quick Contact DNV NEMKO Presafe



Quick Contact DNV NEMKO Presafe



Quick Contact DNV NEMKO Presafe





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