QT Activity: European MDR - EU Access & PMCF
- 2021-05-18 01:53:36
Qualtechs will be holding a Webinar focusing on EU MDR on May 25, 2021.
We welcome all interested guests to join for free.
MDCG has published a guidance for notified bodies on the use of MDASP audit reports in surveillance audit carried out under MDR/IVDR. For those with similar or equivalent requirements, positive QMS conformity result might lead to a reduction of the focus on covered aspect.More
January 8th, 2020 has marked the day of Qualtech’s extensive workshop on the new European Medical Device Regulations (MDR) for its Taiwanese clients. The event provided its attendees with the latest updates on the MDR implementation before the end of the transition period on May 26, 2020.More
On September 17th, IMDRF, the International Medical Device Regulators Forum, has passed the proposal of Medical Device Clinical Evaluation, with unanimous approval of the IMDRF members. This proposal is written by Medical Device Clinical Evaluation Working Group, which is led by China NMPA.More
International Medical Device Regulators Forum (IMDRF) held a meeting in China during March 20 to 22. The current chairman, China FDA, proposed two projects and get the support from all IMDRF members.More