About this document
Class IIa Medical Device Compliance Steps by HARESH NIRMAL is a document available to read on EtoBox.
The document outlines the steps for Class IIa medical device manufacturers to achieve compliance. They must 1) ensure the device classification is Class IIa, 2) choose a conformity assessment route which involves Notified Body certification, 3) compile a technical file, 4) obtain certification, 5) declare conformity, 6) appoint an authorized representative, and 7) conduct vigilance and post-market surveillance activities. The conformity assessment routes for Class IIa devices involve following Annex II for
- Author
- HARESH NIRMAL
- Language
- EN