Medical Devices

Relocation Announcement

DNV GL Nemko Presafe AS moves to new location.
We are pleased to announce Presafe is moving to new office and EX laboratory premises on Monday 12th December 2016.
The Ex lab will represent a major improvement in facilities and functionality.

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/IEC 17021 in Medical Device Quality Management Systems (ISO 13485), the IAF MD 9:2011.

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 now carry out certifications according to the new edition of DS/EN ISO 13485:2012.

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