In order to publicize the Chinese medical device regulations and policies, strengthen the exchange of international medical device regulations and technical norms, promote the experience exchange and interactive learning among medical device evaluation bodies of different countries, improve scientific and technical level of the evaluation, enhance enterprises’ consciousness to obey the regulations, boost communications between enterprises and governments as well as among enterprises themselves, push forward application of new technical standards and technological achievements, further improve safety and effectiveness of medical devices, China Center for Food and Drug International Exchange (CCFDIE) will hold the 7th CIMDR in Chengdu from Sept. 11- 13, 2016.
UL will have five speakers at the event:
Medical Imaging Devices Forum: Tim Lin speaking Sept. 12th on "How to comply with the requirements of IEC 62304 on Medical Device Software" and Victoria Amann speaking Sept. 13th on "FDA medical device Part 21 Chapter 11 Computer System Validation."
Medical Device Clinical Trial Forum (2): Victoria Amann presenting on Sept. 12th on "Medical Device Clinical Data Integrity."
Optics and Ophthalmic Devices Forum: Mr. Jan Peeters presenting Sept 13th,"Interpretation of international standards and evaluation methods of intraocular lenses and contact lenses."
Orthopaedics, Odontological and Surgical Devices Forum: Jan Peeters presenting Sept 12th, "Validation for cleaning, disinfection and sterilization of re-usable instruments" and also Sept 12th, "Understanding material characterization to ensure biocompatibility for medical devices."
Drug-device Combination Products Forum: Merrick Kossack presenting Sept 13th, "Interpretation of Applying Human Factors and Usability Engineering to Medical Devices and Drug-Device combined products."