General Safety and Performance Requirements in the New MDR
The MDR, which replaces the Medical Devices Directive (93/42/EEC) and Active Implantable Medical Devices Directive (90/385/EEC), has a transition period of three years. Manufacturers have the duration of the transition period to update their technical documentation and processes to meet the new requirements. BSI is committed to ensuring a smooth transition for all clients wishing to certify to the MDR, and as part of this we would like to invite you to join our new webinar.
A full gap analysis of the safety and performance requirements in the new MDR against the ERs in the MDD and AIMDD identifies several new requirements and many areas of increased emphasis and specificity. The word count of the MDR safety and performance requirements has nearly doubled compared to the MDD ERs. Some of the new requirements will represent truly new work required of the manufacturer, while others will align with current practice according to harmonized standards and best practices.
This webinar will talk you through the main impacts from the new GSPRs and help you to consider what actions you need to start now to be prepared for the change in requirements; the webinar will urge you to start planning how to meet the new requirements of the MDR GSPRs.
The webinar is supported by a included white paper.
Alexandra Schroeder is a Product Expert and Scheme Manager for the Vascular Devices team at BSI. As a Product Expert for BSI, Alexandra manages CE marking certification schemes and is a technical reviewer for vascular devices including stents and other catheter-based devices. She has been with BSI since 2014. Prior to BSI, Alexandra worked for several years in Product Development for vascular stents at Cook Medical in the United States. She earned a PhD in Biomedical Engineering from Duke University, where she researched methods for seeding vascular endothelial cells onto metallic stent surfaces. Alexandra holds 3 US patents for medical devices and is a contributing author in 10 peer-reviewed research publications.
Maritza Carballo currently leads the vascular technology team focused on providing CE certification services to BSI clients. She has spent the last 9 years conducting CE marking technical reviews of vascular devices and managing a portfolio of clients. Prior to BSI, Maritza spent 12 years in various roles in product development that included drug eluting coronary and peripheral stents, vascular grafts, embolic coils, and other cardiovascular devices, and managed commercialization teams through all phases of development including clinical trials. Maritza earned an M.S. in Mechanical Engineering from Florida International University and was awarded a National Science Foundation Fellowship.
Ronald Rakos has spent over 12 years working in the medical technology industry and 10 years at BSI, where has held a number of positions from Product Expert to Global Head for the Vascular Medical Devices team; he is currently the Operational Effectiveness and Development Lead for the Vascular team. Ron has applied his extensive knowledge of the medical device product development process to the evaluation and assessment of technical documentation for diverse vascular applications. His expertise includes; stents, catheters and associated accessories, vascular grafts, polymer processing, product and process validation and computational analysis. Ron holds a PhD in Chemical Engineering from Stevens Institute of Technology and a MBA in Finance from Rutgers University.