Registration Fees & Deadlines
600 € for SMEs – Priority for SMEs registration (25 places reserved) until March 27th
1200 € for organisation
You can register until April 28th
Event Summary
Clinical Evaluation Review Training for Manufacturers: lesson learnt and the do’s and don’t’s based on non-conformities examples.
This training is directed towards manufacturers/participants who already have experience in creating CER and/or are involved in CE submission. Therefore, the training will focus more on real cases examples and less on introduction or citing regulations.
The topics are presented by MDR experts of designated notified bodies.
The content was elaborated by MDR experts of 3 notified bodies, namely BSI, CeCertiso, Dekra.
This training is intended for participants who are members of a manufacturer’s clinical team and have experience in creating CERs and/or are involved in CE submission. Therefore, can you consider this exper-tise for registrations.
PROGRAM
| 09.00 – 09.30 | Welcome and logistic information | |
| 09.30 – 10.45 | Clinical evaluation routes | |
| Ágnes Horvath, CE Certiso | ||
| 10.45 – 11.00 | Break | |
| 11.00 – 12.30 | How to build sufficient clinical evidence? | |
| Nunung Nur Rahmah, Dekra NL | ||
| 12:30 – 13:30 | Lunch | |
| 13.30 – 14.45 | Post market surveillance and PMCF | |
| Breda Kearney, BSI | ||
| 14.45 – 15.00 | Break | |
| 15.00 – 16.00 | Q&A session | |
| 16.00 – 16.30 | Closing session | |