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

Relocation Announcement

DNV GL Nemko Presafe AS moves to new location.
We are pleased to announce Presafe is moving to new...

IAF MD 9:2011 and the Impact on Audit Duration for Medical Device Manufacturers

The International Accreditation Forum (IAF) has issued a new Mandatory Document for the Application of ISO...

Extension to DGM Denmark A/S' accreditation

DGM Denmark A/S has obtained an extension to its existing accreditation according to 17021:2011 and can...

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