How to tackle your MDR certification process
Virginie Siloret will present the main process step and timelines for MDR certification explaining what are most common issues we are facing as NB during the audit and technical documentation assessment with a final part on the regulation 2023/607 extended the MDD transition period and how manufacturer can benefit from it.
C.V.
Virginie Siloret
Global Medical Device Certification Manager of the Notified Body Belgium N81639 and was previously the Global MDR Product Manager
Responsible for Management of all certification processfrom Contract review to certification decision of medical device certification including ISO 13485, MDD& MDR and soon IVDR.
25 years in Medical Device lndustry in Europe covering active and non-active class 1to 111 devices including Absorbable implants, devices containing medicinal substance with ancillary action. Virginie earned her master’s in food sciences specialized in Microbiology in Dijon (France).