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MEDTEC 2014: Medical Device Innovative Technology Forum and Regulatory Summit
Date:8/8/2014

mables Concentrated Procurement Specification, UDI implementation, FDA updates, US GLP requirements and biological safety evaluation. Senyong Lin, Deputy Director, Medical Equipment Safety Supervision Department of SFDA, and Dr. Zhaohui Li, NAMSA China have been confirmed as speakers.

New design concepts and materials empower device makers

On the afternoon of September 25, another two modules will be held simultaneously - Module B: Design and Innovation of Medical Device & Module C: Application of New Material. These modules will cover many hot topics such as 3D printing, design guidelines for domestic medical equipment in the US, innovation solutions using silicone rubber, high-performance plastics and MIM application.

In these two modules, eminent speakers including Xuebin Zheng, Researcher & Deputy Director, Shanghai Institute of Ceramics, Chinese Academy of Science -- laboratory of inorganic coating; Andrea Bogner, Global Medical Marketing Manager, Wacker Chemie; Dane Waund, Healthcare Global Market Manager, Solvay Specialty Polymers; Tina Wei, Global Marketing Director, Momentive Performance Materials; Jingping Peng, General Manager, JING SHENG Medical and Akhiljit Wangkheimayum, Indo-US MIM Tec will share their expertise.

Risk management and quality control ensure the safety

Safety is a key requirement of any medical devices. Module E: risk management and quality control on the morning of September 26 will address the ISO13485 and FDA-QSR820 standards, and how to cooperate with FDA QSIT inspection and CAPA systems.

Meanwhile, at the exhibition area, MEDTEC China will host a Quality Focus Zone, helping Chinese companies to strengthen quality and process control, reduce costs, and improve value. Instron and BOSE
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SOURCE UBM China
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