Monday, 21st September 2015, BSI hosted a successful Vascular Academic Event in Guangzhou, China. The event attracted 54 delegates. The well-known distinguished guests from home and abroad shared their detailed insights into the current relevant topics for the vascular medical device manufacturers.
The highlights on the event included:
- Dr Ronald Rakos, BSI Global Head of Vascular Medical Device, briefed the audience on “EU Regulatory Updates” and “Top 10 Questions raised in BSI Design Dossiers Reviews”. During his speech, the delegates took notes to accumulate a wealth of knowledge and experience and left the event with a thorough understanding of the updated EU regulations.
- Xinggang Xu, Vice President of Quality and Regulations from Micro-Tech (Nanjing) Co., Ltd, elaborated on “Process Validation”. Mr XU shared with the delegates several case studies. The lecture featured the combination of theory and practice; the talk received a warm response from the audience. An extra lecture, held in the afternoon, focused on practical database management.
- Lily Shi, Regulatory Affair Manager from Lifetech Scientific (Shenzhen) Co., Ltd, delivered a speech on “CFDA Fast Track application for Innovative Medical Devices”. The delegates benefited greatly from Shi’s systematic and targeted explanation for CFDA Fast Track application.
- Xiangdan Kim, Regulatory Affair Manager from Lepu Medical Technology (Beijing) Co., Ltd, shared with the audience “The relationships between risk management & clinical evaluation”. In her speech, she emphasized the importance of risk management in clinic evaluation. The professional and rigorous explanation was highly appreciated by the audience.
- Lane Ji, Scheme Manager of BSI Active Medical Devices, gave a lecture on “The New ISO 13485 – Will You Be Ready?”. Lane’s well-organized lecture made the updated ISO 13485 more understandable.
- Xuhui Wang, BSI MD Technical Manager, gave a brief introduction to “Statistical Requirements for Clinical Trials of non-Diagnostic Medical Device”. Mr Wang’s speech fully demonstrated his academic style and sense of humour. His speech, served as the guidance for statistical requirements for clinical trials of non-diagnostic medical device.
- Shirley Zhang, BSI Healthcare China Director, gave the Welcome Speech and introduction to BSI Medical Device Services and the high-quality expert resources.
- Dr Liang Qian, Asia Pacific Lead BSI Group, in her Closing Speech, commented that BSI, as a world leading notify body, will provide Chinese companies with a platform for technical communication.
(From left to Right: Dr Ronald Rakos, Shirley Zhang and Lane Ji)
The atmosphere in the event was very positive, during the breaks, the delegates made use of the time to benefit from other delegates expertise and experience. Ten lucky delegates won the BSI-customized toy bears presented by the speakers.
Shirley Zhang, Director, BSI Healthcare China
Notes to Editors:
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