MDR Compliance – Key Lessons from a Medical Product Launch

<You can view the webinar recording here>

NXTGEN Hightech Biomedical and High Tech NL cordially invite you to an inspiring webinar on October 17, 2024, from 16:00 to 17:00 CET.

In this interactive webinar, Henk Stapert, CTO at smartQare, will share his extensive experience in the development and market introduction of viQtor, an innovative remote patient monitoring solution. The viQtor received its MDR approval at the end of 2022, and Henk will take you through the journey from concept to market launch and beyond, with a special focus on MDR compliance. This process continues throughout the entire product lifecycle. The connection with IVDR regulations will also be discussed, supported by practical examples. In addition to valuable insights, the webinar will provide an opportunity for interactive discussions to deepen your understanding of the complex medical regulatory landscape.

What to expect:

You will gain insights into:

•         The crucial importance of early regulatory involvement.

•         The key milestones for a successful product launch and how to avoid major consequences from potential mistakes.

Who should attend?

This webinar is intended for professionals in Bio- and Medical Technology and Life Sciences who wish to successfully navigate the complex regulatory landscape and bring their innovations to market faster and more effectively.

Note: There are only a limited number of spots available. Register early to secure your participation!

Do you have any questions in advance? Send them to lifesciences@hightechnl.nl. We will address them during the webinar or afterwards.

Don’t miss this unique opportunity to enhance your knowledge of regulatory requirements and accelerate your path to market success.

Speaker: Henk Stapert, PhD

Henk Stapert is a serial entrepreneur and innovation manager with over 15 years of experience in healthcare, both in corporate venturing at Philips and in privately funded startups. He is currently CTO at smartQare, where he develops groundbreaking technologies such as the aforementioned viQtor for patient monitoring.

His impressive career includes leadership positions in project, program, and R&D management, business development, and global innovation portfolio management. Some of his successful innovation programs include Biocartis' Idylla diagnostics platform and the Onvision ultrasound guidance platform, brought to market by Philips and B. Braun.

Henk holds a master’s degree in Chemical Engineering from the University of Twente, followed by a PhD in Biomedical Engineering. After a fellowship at the University of Tokyo, he joined Philips, playing a key role in various innovations. With more than 25 granted US patents and as a sought-after speaker, Henk brings unique insights into innovation and regulations.