Introduction

Agenda

Speaker

Sponsor/Package

Registration

Transportation

The 3rd Edition of Regulatory Lecture: Best Practice for Product Compliance and Market Launch

Sep 15 | Conference Room A, Hall 2 of SWEECC

Organizers:  Medtec China

Conference Target

• Exploring the key regulations and compliance strategy of medical device industry
• Looking for approaches to speed up the launch of medical devices
• Jointly promote the innovation and development of medical device products
• To provide a platform for medical device regulatory engineers for interaction and communication cooperating with the exhibition

Conference content

• 1. Medical device pre-clinical animal study and data analysis
• 2. How manufacturers adapt the update of clinical trial regulatroy to accelerate market launch
• 3. Interpretation of the Guidelines for Technical Review of the Establishment and Characterization of Evaluation Methods for Unknown Leachable of Medical Devices
• 4. Medical Device Toxicology Risk Assessment Based on ISO 10993-17
• 5. Medical device preclinical large animal experimental operation case sharing
• 6. Efficacy test of disinfectants for production environment

Who Should Attend?

• Registration, QA&QC, Compliance, Medicine, R&D Department, Project Manager/Director and Managing Director from medical device manufacturers

• Surveillance organization and research institution

• Regulation, testing, certification, verification, clinical trials and other services suppliers

>> Download the agenda of MEDTEC China 2020

Lee Fu, Vice President, Mid-Link Group Company Limited

Xufeng Wei, Director & Deputy Director of Cardiac surgery, Scientific Research Department, Ming Xin Cardiovascular Disease Hospital of Wuxi

Dongdi Sun, Ph.D.; Director,Chemical Laboratory, WuXi AppTec China Testing Center

Xueping Xu, Leader of Regulatory Affairs, WuXi AppTec China Testing Center

David Moddrelle, Senior Director of Surgical Services, WuXi AppTec China Testing Center

Jia Wen, Ph.D.; Leader of Microbiology Laboratory, WuXi AppTec - Medical Device Testing Center

Complete guest Introduction Download

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Conference Room of Shanghai World Expo Exhibition & Convention Center

North Entrance, No. 850 Bocheng Rd. Shanghai

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