Meet & Greet with Jan-Paul van Loon at the 10th China Trial: Medical Device Clinical & Regulatory Sr Leader’s Summit

06-10-2017

2017-10-06

“医疗器械- 临床和法规论坛” 将于2017年11月8日在上海JW万豪酒店举行,此次峰会主题设为“吸取2017年的经验与见识,为2018年的医疗器械行业做好改进的准备!" 重点围绕近期欧盟法规、CFDA和东盟法规的更新展开讨论。

The "Medical Devices - Clinical and Regulatory Forum" will be held at the JW Marriott Hotel in Shanghai on November 8, 2017. The theme of the conference is "Learn from the experiences in 2017 and experiences for the 2018 medical device industry. Ready to focus on the recent EU regulations, CFDA and ASEAN regulations to discuss the update.

 

Qserve代表 Jan Paul博士将发表“欧盟医疗器械法规-如何执行临床试验和临床评价”的主题演讲,和与会者分享欧盟MDR对企业执行临床试验和临床评价提出的挑战及其对技术文件准备提出的要求,同时强调PMCF法规要点及其结合预期用途、风险管理和临床评价的必要性。

Qserve consultant, Jan Paul van Loon, will deliver keynote speeches on "EU Medical Device Regulations - How to Perform Clinical Trials and Clinical Evaluation", and share with participants the challenges posed by EU-MDR to implement clinical trials and clinical evaluations and their preparation of technical documents Requirements, while emphasizing the need for PMCF regulations and their combination of intended use, risk management and clinical evaluation.

 

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智服中国是一家专注于医疗器械领域的专业团队,提供产品注册,法规合规,临床评价和法定代表人等服务。

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