Wednesday, February 24, 2021
HRB CRCI in conjunction with Enterprise Ireland will hold a webinar addressing the Medical Device Regulations coming into force in May 2021 on Feb 24th and 25th. The regulations will replace the existing Medical Device and Active Implantable Medical Device Directives.
Key changes include the importance of the Quality Management Systems (QMS) based upon the ISO standard ISO 13485 and the increased emphasis on clinical investigation. These topics will be addressed along with input from our competent authority and a notified body. Experts from the Clinical Research Facilities in Ireland will speak to the clinical investigation process.
The webinar will be comprised of 4 sessions over 2 days. For further details on the agenda and how to register for the sessions, please check out the attached flyer.
Thanks & Kind Regards,
Please see full details here: /hri/sites/hri/files/user_media/Hold-the-date-flyer-HRB-CRCI-8-Feb-2021-v3 final.pdf