Medical Regulations & Standards

Regulations & Standards

MDD/CE-marking

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

IVD/CE-marking

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

ISO 13485

ISO 13485 certification is relevant 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

ISO 9001

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

Taiwan Technical Cooperation Program

Presafe 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 quality manageme

Medical News

New Medical Device Regulation

What does it mean for manufacturers?
...

Unannounced Audits

The European Commission Recommendation 2013/473/EU on audits and assessments performed by...

RESPONSE TO NEWS PUBLISHED BY THE DANISH MEDICOINDUSTRIEN

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

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