Suzhou Ireland Medical Equipment Co.,Ltd. Posted on: Shanghai October 16, 2015 - The September 25 by TUV SüD (hereinafter referred to as "TUV SUD") organized by the Department of healthcare services, "Clinical Evaluation of EU research meeting "held in Shanghai, the EU aims to transfer the latest medical device clinical requirements to Chinese enterprises in a timely manner by the relevant applicable standards and guidelines for analysis, to help companies understand the correct clinical assessment of practical significance and regulatory requirements. Day total of more than 200 customers visit the site, including Siemens, Philips, Mindray, Shanghai Alliance shadow, minimally invasive medical, camel and the creation of the Group and other well-known medical medical equipment manufacturers.
Accident means injury to the patient, but also for the survival of great destructive power. Thus, the collection of clinical data and design of clinical trials of paramount importance. In practice, however, many manufacturers do not know in the end what is "clinical data", what type of data, the range of values to meet EU regulations, how to prove a clinical benefit or risk ratio determined. The issue has become more and more restricted medical equipment EXPORT shackles. With the increase of China's export level of risk, clinical evidence of compliance chain more and more attention. To help domestic medical device manufacturers, TUV SUD as the world's leading medical device industry certification testing service provider, invited the Director of Clinical Affairs Bassil headquarters from Munich, Germany, Dr. Akra came to Shanghai as we explain.
During the forum, TUV SUD expert for the EU regulatory guidelines and harmonized standards including MEDDEV 2.1 / 3, MEDDEV 2.7 / 1, MEDDEV 2.12 / 2, EN ISO14155 do a detailed interpretation. Finally, he brought medicine medical equipment, medical devices containing clinical requirements were human blood products include, clinical evaluation report on the review of the typical problems encountered while manufacturers were summarized.
TUV SUD Greater China President Chen Zhaohui, director of healthcare services, said: "medical device clinically proven medical device R & D an integral part of the scientific program of clinical assessment is to protect an important part of safe and effective medical devices .TUV SUD is a leading global Third-party testing and certification organization, will rely on a global team of clinical, clinical assessment for the enterprise segment provides global services to help China to the world. "