Medical Services

Services

Medical Device Services

Presafe´s team of experienced compliance specialists and auditors offers you a highly skilled and cost-effective ticket to trade to the global markets.

Certification

Product must carry the CE-mark to be permitted for sales in the EU. Additionally, an increasing number of other markets around the world require CE marking on medical devices.

Complaints

Handling complaints, disputes and appeals

Unannounced Audits

Information about unannounced audits performed by Notified Body

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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