Dear All
The basic primer on how to obtain European CE marking for a medical device is published by Emergo group as a video format, and the 11 minute video is available in YouTube. It’s explains the European CE marking process and how to get a medical device approved for sale in the EU, explains device classification, Technical File preparation, ISO 13485 quality system implementation, role of the EU Authorized Representative and Notified Body audits. The flow charts make the process easy to understand. To view full presentation refer
Regards
S. Subramaniam
The basic primer on how to obtain European CE marking for a medical device is published by Emergo group as a video format, and the 11 minute video is available in YouTube. It’s explains the European CE marking process and how to get a medical device approved for sale in the EU, explains device classification, Technical File preparation, ISO 13485 quality system implementation, role of the EU Authorized Representative and Notified Body audits. The flow charts make the process easy to understand. To view full presentation refer
Regards
S. Subramaniam