Posts

Showing posts from January, 2011

Notified Body Short List

Sam Lazzara Resume LinkedIn Profile   Documents Services Schedule Call   +1 510 397 9739 sam@lazzara.net This link shows quality system registrars who are recognized by Health Canada:  Health Canada Happy Registrar List The fact that these bodies have gone to the trouble and expense of seeking Canada recognition is indicative of their commitment to medical device quality system registration. If you ever want to market devices in Canada you will need to be using one of those registrars. Canada will only accept quality system certificates that have been issued by special third party auditing organizations called Canadian Medical Devices Conformity Assessment System (CMDCAS) recognized registrars.  There are 74 Notified Bodies for the Europe Medical Device Directive (MDD) and 19 Notified Bodies for the Active Implantable Medical Device Directive (AIMDD).  - 14 of the "MDD 74" are on the Canada list - 8 of the "AIMDD 19" are on the Canada list