|
Revised Conduct Code for Notified Bodies Details Unannounced Audits
European notified bodies (NB) must conduct unannounced inspections of medical devicemakers at least once every three years for Class I, IIa and IIb devices and once every two years for Class III and active implantable medical devices (AIMD), according to the new code of conduct released by the European Association of Notified Bodies Oct. 10.
This article is viewable by subscribers only. To view this article, please select an option below.
|
Related Articles
Devicemakers Must ‘Act Now’ on Objections to EU Device RegulationsRapporteur Seeks Stricter Controls Over Clinical IVD Trials, Genetic TestingIVD Makers Face ‘Quantum Leap’ in Requirements Under Proposed EU RegRapporteur for IVD Regulation Seeks Stricter Controls Over Clinical Trials, Genetic Testing
|
Subscribe
Archives