Korea University Medical Center & TÜV SÜD to actively address EU Medical Device Regulation
Both organizations agreed to cooperate in the improvement of safety and effectiveness of Korean medical devices
KUMC is the first of its kind in Korea, proactively trying to address MDR and IVDR
Establishing a milestone as an international clinical testing hub for medical devices
Korea University Medical Center (KUMC) is to cooperate with TÜV SÜD, a leading testing and certification body. With this agreement, KUMC becomes the first of its kind in Korea to proactively address EU’s medical device regulations which have been strengthened. It also aims for improving the safety level of the domestic medical device industry as well.
On August 6th, KUMC and TÜV SÜD signed an MoU to deal with the requirements of EU medical devices regulation and to cooperatively work on the development of the medical device industry in Korea. The ceremony was attended by 15 representatives from the Korea University Medical Center and TÜV SÜD including Kee-Hyoung Lee (President of Medical Center at the Korea University Medical Center), and Wolfgang Hock (President of TÜV SÜD Korea), Dr. Bassil Akra (TÜV SÜD Product Service GmbH MHS Board Member), Volker Jesse (Senior Vice President of TÜV SÜD Korea) and Aaron Oh (Vice President of TÜV SÜD Korea).
KUMC is the one who has two R&D medical centers in Korea. Last December, three hospitals of KUMC were fully accredited by the Association for the Accreditation of Human Research Protection Program (AAHRPP). Based on its outstanding biomedical fusion R&D capability, KUMC has decided to cooperate with TÜV SÜD to ensure that the medical devices developed by domestic manufacturers attain global level of safety and achieve its claimed performance criteria.
"We are very pleased to sign an agreement with TÜV SÜD, a globally recognized testing and certification body with more than 150 year of history," said Prof. Kee-Hyoung Lee, Executive Vice President for Medical Affairs and President of Medical Center at the Korea University Medical Center. "It is very meaningful that our Korea University Medical Center will be able to help domestic medical device companies for successful global market access," he added.
"We are also very pleased to cooperate with KUMC, one of the leading and innovative medical centers in Korea," said Wolfgang Hock, President and CEO of TÜV SÜD Korea. “I look forward to reviving the medical device industry in Korea based on strong partnership with KUMC. "
Dr. Bassil Akra, TÜV SÜD MHS Board Member, said, " I am looking forward in identifying new areas of interest in the medical device field in Korea where our competence as an independent testing and certification organization can add value through this cooperation, just like TÜV SÜD was brought out to address steam boiler explosion 150 years ago. Both TÜV SÜD and KUMC aim to contribute to well-being, safety and life of patients who are exposed to innovative medical device technology. We will do our best to make sure Korea’s medical devices are tested and studied under conditions which are recognized in the global market."