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Interview with Michael Yan, Regulatory Affairs Expert

We would like to get you all acquainted with our Regulatory Affairs Expert. An interview where we talk about his expertise, how a normal workday looks like and which trends he observes in the MedTech-world. Ending the interview with valuable advice for everyone in the MedTech world!

Let's start with a small introduction, could you tell me something about yourself?

I am always curious and passionate about all the new things, and I have a great interest in unknown knowledge, which makes me always would like to take the challenges and try to make traditional work more creative.

What is your main area of expertise?

NMPA regulations, including type testing, technical documentation build-up, and clinical evaluation. Also, participant CE mark projects under MDD and MDR.

Could you also tell me something about your experience before you joined Qserve?

Before joining Qserve, I was working in the industry for more than 12 years, focusing on regulatory affairs, including clinical evaluation. I have worked for both domestic and international companies with different types of medical device registration experiences.

Most of the time, I prepared product technical requirements (PTR) and conduct type testing based on that. For some special devices, the type testing was done in a third-party test lab overseas. And finally, complete all submission dossier for products, including X-ray diagnosis devices, Image Guided Surgery System, Deep Brain Stimulation (DBS) system related products, Radiotherapy System, Proton therapy system, and software as medical device.

I also conducted several clinical studies in China according to China GCP for the products of imaging workstation (SaMD) and Blood Glucose Monitoring System.

For the previous works, I was mostly focusing on the foreign manufacturers’ products registration in China, now in Qserve, I have more opportunities to help clients for CE certifications.

Which part of your job do you like the most?

I can keep meeting different companies and different products with innovative technologies, which bring challenges to me, and in the meantime, I can learn a lot from them. When doing a project, I could provide advice to the client and help them to solve problems, and I shared happiness with the client for success.

How does a normal workday look like?

During this special time I stayed at home, all discussions are online, and there are more and more virtual training and webinars available, I am also preparing some training materials myself. It can be a chance to learn and organize knowledge systematically, but I hope this can be gone quickly, and we all go back to normal life, in which we do public training, onsite supporting, as well as other different types of consulting.

Do you prefer a specific type of medical device?

I have more experience on active medical devices in the past, so I can deal with this kind of device smoothly, but I hope I could be involved in non-active devices, as well as other products.

Which trends do you observe at the moment?

I think many people in the medical device sector are taking the time to collect information and arrange their long-term plans and projects. Of course, many training and webinar are also an excellent way to increase our knowledge. For the topics in the regulatory field, the software and cybersecurity, artificial intelligence are getting hotter.

How do you stay up to date with everything that is happening in the MedTech-world?

I believe to better stay up to date the regulation and requirements, and it is necessary to go through the practical way to get more experience from the real projects. Training, webinar, and social connections of regulatory peers are also an easy way to know what is happening out there.

What is your advice/message for our customers?

Use the downtime to lay a solid foundation for the challenges and be ready for the new normal.

Would you like to know more about Michael? Click here for her full profile.

Michael Yan
Post date: August 12, 2020
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