List of Contributions

Hi Hassna, This is possible as I have had clients who have done just that. The ISO 13485:2016 MDSAP certificate would have to contain the normal scope for the risk class of the device (ie specification, design and manufacturing) and then the OEM would be a "qualified vendor" under the distributor's ...

Hi Christine, If the manufacturer clearly labels the device as "not for human use" and "for demonstration purposes only", both directly on the device (if possible) and on the labelling (box, IFU etc) and put it in the shipping documents too, you should be ok to import it for this purpose and there ...

Hello everyone, I would be interested in joining the local chapter. Thanks for all the effort to get this going. ​Shirley ------------------------------ Shirley Furesz, Ph.D, RAC Director, Regulatory Affairs Medical Devices Oakville Canada ------------------------------