The seminar "Strategies for MDR/IVDR Success" was successfully held by PYQ Lab (Suzhou) Co., Ltd. and IMQ Certification (Shanghai) Co., Ltd., and co-sponsor Suzhou Industrial Park Enterprise Joint Open Innovation (SIP ENJOI) in the afternoon of July 26th, 2024.
Daniele Bollati, IMQ Technical Manager of non-active medical devices, navigated the new European regulations as well as clinical/performance evaluation with case studies for MedTech companies. Boasting rich R&D experience on non-active medical devices, he has carried out activities of accessing the conformitiy of medical devices(technical file evaluation and onsite audit) since 2015.
Dayong Wang, PYQ Lab Manager, introduced PYQ Lab and talked about IVDR technical documentation. Having much experience in R&D of IVD prodcuts and raw materials, and working in foreign medical companies, he once worked for the registration of NMPA Class III IVD products and the filing of Class I IVD products, and is also familiar with the operation and audit of QMS.
The participating companies are expected to acquire valuable certification experience and guidance, as well as open new ways of tapping into overseas markets.
Moments
Daniele Bollati, IMQ Technical Manager of Non-active Medical Devices
Dayong Wang, PYQ Lab Manager