Centaur Clinical sets up the post-marketing clinical surveillance (SCAC) of your device according to the MEDDEV2,12/2 Rev8. SCAC is a requirement of the new regulation 2017/45 and consists of collecting real life clinical data with the aim of monitoring the safety and performance of a medical device once it is placed on the market and until the end of its life cycle.
- Assessment of the applicable framework
- Evaluation of the criteria for confirming performance and safety claims
- Implementation of the SCAC plan and clinical study if necessary
- Analysis of clinical data
- Writing the SCAC report