Webinar: AIMDD to MDR transition – what you need to know

What’s the webinar about?

The webinar provides an overview of important topics to be considered when transitioning from the Active Implantable Medical Device Directive (AIMDD) to the Medical Device Regulation (MDR). 

Who should attend the webinar?

This webinar will offer notified body insights for all people involved in working towards a MDR application, whether you are a novice or have significant experience of working with a notified body.

What will participants gain?

Join this insightful webinar to hear from Thomas Doerge, BSI’s Global Head of Active Implantable Medical Devices, talk about MDR lessons learnt so far for AIMD products, as well as tips on making applications and the Technical Documentation requirements under the MDR. In this webinar, Thomas Doerge will also be joined by subject matter experts Concetta Gallo and Jazzmyne Buckels. The webinar provides an overview of important topics to be considered when transitioning from the Active Implantable Medical Device Directive to the Medical Device Regulation.

Thomas has an in-depth knowledge of Biomedical Engineering, Biomedical Microsystems and Medical Engineering & Neuroprosthetics, which includes micro-structuring, manufacturing, wireless energy and signal transmission, as well as the characterization of active implantable systems.

He is leading a global team of 23 Product Technical Specialists and dedicated clinical experts who are not just experienced in the regulatory process, but are product experts who understand the specifics of active implantable products.

Concetta Gallo has 10 years’ experience in the Research and Development of AIMD products in the field of Cardiac Rhythm Management.

She holds a degree in mechanical engineering. Her in-depth knowledge of Biomechanical Engineering is supported by several years of experience in design, prototyping, testing, manufacturing and engineering of innovative and standard cardiac leads, pacemakers and defibrillators.

Concetta joined BSI in 2017 as Product Specialist and Scheme Manager, and she is now leading part of the AIMD technical team as a Technical Team Manager.

Jazzmyne Buckels has a degree in Biomedical Engineering with over 12 years of experience in Active Implantable Medical Devices.  Prior to her 5 year tenure at BSI, Jazzmyne was a Research & Development as well as Clinical Engineer specializing in Neuromodulation.  She also holds 4 active patents for Spinal Cord Stimulation leads and tools. Driven by patient safety, she takes pride in making sure that devices certified by BSI are state-of-the-art.

As a Technical Team Manager, her goals include streamlining the review process and facilitating the understanding of relevant regulatory requirements both internal and external to BSI.