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DNV Nemko Presafe A/S is a global testing and certification company specialized in two industries: Medical devices and equipment used in hazardous locations or potentially explosive environments, so called “Hazloc” or “EX” equipment.

We provide worldwide market access for our customers´ products through a global pres¬ence with efficient and reliable testing and certification services based on EU directives and international safety and quality standards.

Read more about our services for medical devices here and EX/Hazloc equipment here.

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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.

With Presafe, you can enjoy an extensive reach and service offering, reduced time to market, and foremost, a trusted partner!

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Medical device courses 2016

Presafe Denmark A/S provides courses for the medical device industry.

ISO 13485:2016 - upgrade...

Ex-Conference 2016

The 14th National Ex Conference is aimed to topics related to hazardous locations and will find place 22-...