Key takeaways and learning objectives
During this course, we will look at the background to the introduction of this new EU MDR requirement: Article 18, Implant card and information to be supplied to the patient with an implanted device.
We will review the Article 18 text and discuss the types of questions that Notified Bodies may ask when conducting conformity assessment against Article 18.
Kevin manages a portfolio of medical device manufacturers and is involved in the review and evaluation of cutting-edge innovation and state of the art orthopaedic and dental technologies. He holds a BEng in Biomedical Engineering from the University of Limerick, Ireland and postgraduate diplomas in Project Management from IPMI. Kevin has over 12 years medtech industry experience and a track record of success in leadership roles in the research, development, commercialization and regulation of medical technology.
Join Kevin Madden, Training Lead & Technical Team Manager with the Orthopaedic & Dental Team at BSI Medical Devices for our webinar on Implant Cards.