The Summary of Safety and Clinical Performance (SSCP) is a document that is with a unique structure and format: it is intended to include detailed information on a medical device for both healthcare providers and patients and will be available for the public.
Many manufacturers already know how to write an SSCP.
We also have read MDCG 2019-9, but how can we go from good to excellence? And how can we improve a document which will be public soon?
To be able to work on your SSCP you need strong technical skills. You also have to be able to translate the technical documentation into lay language: Are we complying with a regulatory requirement or are we really communicating with the public?
Consistency with the Technical Documentation, different expectations from the manufacturer and the Notified Body and strict timelines are additional hurdles.
This workshop will navigate you through the needed skills to achieve excellence and positively impact the final document.