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MEDTEC China 2013: Conference Program Closes in on Finalization
Date:8/27/2013

an, Regional Lead & Orthopedics Expert, British Standard Association entitled "Clinical data requirement for EU high-risk medical products." Dr. Liang's presentation is augmented by three others by Chinese speakers, including "Challenges of clinical trial for medical device: application of statistic" (Wei Li, Director & Professor, Director for National Center for Fuwai Cardiovascular Diseases China), "Exploring solutions for clinical trial of medical devices according to Provisions for Medical Device Classification published by SFDA," and "Case Study: clinical trial of bioabsorbable vascular stent" (Dr. Guixin Shi, R&D Director, Beijing Advanced Medical Technologies).

In parallel once again is Module F: Risk Management & Quality Control. The first presentation in this session is "How local manufacturers establish concrete compliance evidence to satisfy FDA QSIT inspection" (Scott Yu, an independent regulatory consultant). Following on are presentations on "Safety evaluation of new type biomaterial and quality control of medical devices" (National Institutes for Food and Drug Control), "Risk analysis techniques and methodology for medical device and how to apply them to control product quality" (a sponsor presentation by Pacific Bridge Medical), and a second presentation from Lane Arbittier, QA & RA Expert in Zimmer entitled "Implementing ISO13485: Quality Management Systems effectively and understanding the new standards from US & EU regulatory bodies."

With such a strong program, the organizers anticipate intense interest from show visitors in all of these modules. For this reason, they suggest that show attendees planning on participating in the conference turn up early and secure their seats. The organizers look forward to welcoming all attendees to the MDiT Forum and Regulation Summit 2013. Please click
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