Registration Fees & Deadlines
For SMEs – Priority for SMEs registration (25 places reserved) until September 25th
1 person : 450€
2 persons : 750€
For organisation
1 person : 900€
2 persons : 1500€
You can register until November 30th
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? | |
| Q&A moderated IVD expert | ||
| 12:30 – 13:30 | Break | |
| 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 | |
Cancellation policy for training attendance
- Cancellations must be notified in writing to Team-NB as soon as possible and, in any case, no later than 24 hours before the start of the training.
- For cancellations received less than 24 hours before the start of the training, no refund will be granted.
- A registered participant may be replaced by another person from the same organisation, provided that Team-NB is informed before the start of the training and receives the replacement participant’s details.
- No-shows will be treated as late cancellations and will not be eligible for refund.
- If Team-NB cancels or postpones a training, registered participants will be offered either a full refund or transfer to a new date, where available.