We are sincerely privileged to invite you attending the Clinical Evaluation Seminar from Dec. 18 -19 in Shanghai.
As acknowledged, China has become one of the biggest medical devices export countries in the world. With the ascending product risk, European notified bodies and competent authorities are paying more attention to the clinical evaluation part of the manufacturers’ technical documentation. Clinical evaluation is one of the most important works before medical device registration for evaluating safety and effectiveness of the devices. Important regulatory guidance / standards in Europe are MEDDEV 2.1/3, MEDDEV 2.7/1, MEDDEV 2.7/4, MEDDEV 2.12/2 and EN ISO 14155. Also, these regulatory guidance / standards are used by notified bodies and competent authorities as the most important assessment criteria. This seminar is hereby to enhance the understanding of these directives and standards.
- Manufacturing, R&D and registration personnel
- Drafting and Maintaining the CE technical file personnel
- Other related person interested in Clinical Evaluation
Venue：Grand Ballroom on 3rd floor
Cost：4,000 RMB per person (dinner, materials, and etc included, accommodation excluded)
(all the fee above V.A.T. included)
Standard room RMB 770 with two breakfast, single room RMB with one breakfast. We can book the room for you if needed.
Click for more information [ PDF 645 kB ]