Webinar: Medical Device Regulation Lessons Learnt

What’s this webinar about?

The Medical Device Regulation (MDR) Date of Application (DoA) is approaching. The timelines for ensuring your product maintains EU market access under the new, more stringent MDR are challenging. BSI Notified Body wants to share some of our experience working on Technical Documentation submitted under the MDR.

Who should attend the webinar?

This webinar will offer notified body insights for all people involved in working towards an MDR application, whether you are a novice or have significant experience of working with a notified body. We will not focus on any specific medical device type, more on the gaps we see in current applications.

What will participants gain?

Join BSI's Kevin Madden, Team Training Lead and Technical Team Manager in the Orthopaedic and Dental technical team, to hear the critical lessons we have learnt and how you can use these to improve your submissions to BSI. We will share notified body experience and common pitfalls and learnings. Kevin will be joined for the Q&A section by Chris Wylie, Global Head, Orthopaedic & Dental Devices, BSI.

Kevin Madden is a Team Training Lead and Technical Team Manager with the Medical Devices Regulatory Services Team at BSI, which he joined in 2015. Kevin is an accomplished biomedical engineer with a proven track record of success in leadership roles in the research, development, commercialisation and regulation of medical technology and has over 16 years of experience in the orthopaedic and dental industry.

Prior to joining BSI, he worked in several R&D and manufacturing roles at Stryker Orthopaedics and was Managing Director at PBC Biomed. Kevin is a graduate in Biomedical Engineering from the University of Limerick, Ireland.

Chris Wylie has worked at BSI since 2008 covering roles across Scheme Management, Technical Review, QMS auditing and most recently supporting the overall management of the Orthopaedic and Dental technical team.

Chris is a Medical Engineering graduate, has previously worked as a metallurgist and conducted various academic research projects and PhD relating to orthopaedic joint replacements and dental materials.