• 2022-05-26 13:46:04

Japan's Adverse Event Glossary are amended to match with the IMDRF's terminologies.

• 2021-12-27 05:35:39

The Japan Federation of Medical Devices Association (JFMDA) has arranged the Japanese “Adverse Event Glossary” and created a mapping chart to match with IMDRF's Adverse Event terminologies.

• 2021-06-29 11:30:23

On 25th June, Qualtech and ISS AG jointly hosted an enriching webinar session on the newly implemented Medical Device Regulation MDR (EU) 2017/745 (MDR) and the dynamic European medical device landscape. In this article, we are looking at the important points discussed.

• 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.

• 2021-01-08 02:18:25

We have European MDR Online Training with Croma – Director of Regulatory Affairs Mr. Arkan Zwick and Head of RA-GCD, deputy QPPV at Croma Ms. Alexandra Baer

• 2020-09-15 06:35:40

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.

• 2020-02-21 07:27:21

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.

• 2020-02-21 06:51:47

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.

• 2020-02-12 14:16:42

• 2020-02-14 07:35:54

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.