Introduction

Agenda

Speaker

Sponsor/Package

Registration

Transportation

The 2nd Edition of Regulatory Lecture: Best Practice for Product Compliance and Market Launch

Sep 26, 2019 | Conference Room B, 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

• Updates from U.S. FDA/CDRH 2018/2019
• MDR transition period is coming to an end, how should medical device enterprises deal with it
• The relationship among manufacturers, suppliers and Notified Body in the new EU regulations
• Impact of MDR on Pre-clinical Testing
• Chemical characterization of medical device- case studies for extractables assessment of orthopedic products
• Animal Surgical Experiments on Medical Instruments——Animal Surgical Experiments of Implants and Interventional Instruments
• Similarities and Differences between Medical Devices and Drug Clinical Trials

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

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• Hongtao Fu, Shenzhen Joyantech Consulting Co., Ltd.
• Nan Zuo, Director, Regulation Registration Division of WuXi AppTec
• Xiaolong Rong, Technical Director, Chemistry Laboratory of WuXi AppTec
• Yuzhu Sun, Surgeon, Surgical Services of WuXi AppTec
• Xiaoying Gao, Senior Project Manager；Strategic Management Manager, WuXi Clinical

>>Register now

Conference Room of Shanghai World Expo Exhibition & Convention Center

North Entrance, No. 850 Bocheng Rd. Shanghai

Hotel Reservation