TÜV SÜD China North Region will hold 3 days Training in Dalianabout the Medical Device Regulation duringSep 22nd -24th , 2014. The
following theme willbe discussed,MDD directive, Risk Management, and clinical Evaluation.
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. 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.
2. Who should attend?
- Manufacturing, R&D and registration personnel
- Drafting and Maintaining the CE technical file personnel
- Other related person interested in Clinical Evaluation
Ms. Lian Hongwen – TÜV SÜD Great China, North Region MHS Manager
Medical Devices Lead Auditor / Notified Body Auditor / Senior Lecture
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