Key Person of Team:
| Lisa Han lLisa Han holds BS in Biomedical Engineering, she is engaged in medical device regulation research for more than 10 years, medical device regulation expert. Successfully handled more than 200 NMPA registrations. lShe used to be the QMR in large domestic medical device manufacturing company, and participated in the product registration, clinical trial, production management of multiple products. Familiar with the whole life circle of medical device. lShe was the Regulatory Affairs manager in the largest consulting company in China, with rich medical device registration experience, especially having a strong ability for high-risk medical device registration. lShe is Regulatory Affairs director and co-founder of Beijing Regis Solution Co., Ltd. |
| Steven Mijit lHe holds BA in English Literature from the University of International Relations, engaged in medical device regulation research for 8 years, medical device regulation expert. lHe used to be invited to Japan, the United States, and Europe to introduce Chinese medical device regulations. lHe was Key note speaker in AdvaMed introducing China medical device regulation system. lWorked as the Deputy director of business development department in the largest consulting company in China. With rich knowledge of medical device products and regulations, and excellent communication ability in English, he facilitates the communication between NMPA and overseas medical device companys. lCurrently as business development director and co-founder of Beijing Regis Solution Co., Ltd. |
| Ada Zhang lShe holds BS in Biomedical Engineering and engaged in China medical device regulatory affairs for more than 6 years, she participated in more than 100 medical device NMPA registrations including a number of high-risk products. lShe has profound expertise across NMPA regulation, registration management, process optimization. lJoined in Beijing Regis Solution Co., Ltd in 2017, and currently working as the project manager. |
| Vicky Fu lShe holds BS in Biotechnology and engaged in China medical device regulatory affairs for more than 6 years, she participated in more than 100 medical device NMPA registrations including a number of high-risk products. lShe worked in several well-known medical device multi-national companies as regulatory affairs specialist in China, with strong project implementation and communication ability. She has experience of successful NMPA registration of more than 100. lShe Joined in Beijing Regis Solution Co., Ltd in 2017, and currently working as the Project manager. |
