Content
The seminar will present the meaning and purpose of the “Summary of Safety and Clinical Performance” (SSCP). This includes both the contents of the SSCP and, in particular, the sources from which the SSCP is to be fed in accordance with MDCG 2019-9 Rev. 1.
The participants are also introduced to the pitfalls that often occur when submitting to the notified body and how they can be avoided. In addition, the Notified Body's requirements for the SSCP are discussed, especially with regard to the SSCP part that is to be prepared for patients (= laypeople).
Topic overview
- Meaning and purpose of the SSCP
- Contents and sources of the SSCP
- Structure, structure and stylistic requirements for the SSCP
- Tripping hazards and how to avoid them
- Expectations and requirements of the notified bodies
target group
Employees from the areas of clinical and regulatory affairs, product management, business development, project managers, consultants, service providers for medical devices, authorities.
Prior knowledge
Knowledge of the EU MDR is recommended.
Funding opportunity
ESF funding is possible. Further information can be viewed here .
Early bird discount
If you register up to 3 weeks before the start of the seminar, you will receive an early bird discount of 10 percent.
KONTAKT:
Online
