Medical Regulations & Standards

Regulations & Standards


The Medical Devices Directive 93/42/EEC defines safety and performance requirements for medical equipment sold in the European Union.


IVD (In Vitro Diagnostics) devices are regulated by EU Directive 98/79/EC of 27. October 1998.

ISO 13485

ISO 13485 certification is suited for all medical devices manufacturers and suppliers.

ISO13485 under Canadian Medical Device Regulations

Medical device manufacturers who want to access the Canadian market must, as part of the requirements to obtain and maintain a medical device license from Health Canada, be registered in accordance

Taiwan Technical Cooperation Program

Presafe´s subsidiary DGM Denmark A/S is a recognized partner of the Taiwan technical cooperation program and is authorized by the Taiwanese authorities to audit against the specific requirements on

ISO 9001

ISO 9001 certification is suited for all sectors and companies that want to focus competitively on customer needs and product quality.

Medical News

Press Release - DNV GL acquires 100% ownership of Presafe

DNV GL announced today that it has acquired 100% ownership of the EU Notified Body DNV GL Nemko Presafe AS...

Response to news published by the Danish Medicoindustrien

Please be aware that a ”breaking news” has been released from “Medicoindustrien” (a national association...

Digitally signed documents issued by DNV GL Presafe AS

We use digital signatures on documents, such as certain certificates, reports and letters, for example....

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