The European Commission Recommendation 2013/473/EU on audits and assessments performed by notified bodies in the field of medical devices was published on September 24th 2013.The purpose of the Recommendation is to enhance patient safety especially following the Poly Implant Proth
RESPONSE TO NEWS PUBLISHED BY THE DANISH MEDICOINDUSTRIEN
Please be aware that a ”breaking news” has been released from “Medicoindustrien” (a national association within MedTech Europe) informing that Presafe Denmark A/S will close, that all certification activities will be moved to Presafe headquarter in Norway and that this will lead to a change of th
Registrering af fabrikanter af medicinsk udstyr
Siden 2014 har alle nyetablere fabrikanter af medicinsk udstyr uden hensyn til klasse skulle registreres hos Sundhedsstyrelsen.