The deadline for the new EU Medical Device Regulation is fast approaching.
The new regulation which becomes fully applicable on May 26, 2021 aims to create a robust, transparent, and sustainable regulatory framework, and ensures high level of safety and health for patients and users.
Our team, led by Dr Tina Amini has identified several hurdles accompanying the new regulation that could challenge the process of making your medical device compliant with the updated requirements in time.
To help you prepare, Tina has created an easy-to-follow webinar series, starting on Thursday January 14th, which will address each hurdle in turn.
Tap into Tina’s extensive knowledge and together unlock the enigma of Medical Device Regulation.
Session 1: Introduction to EU Medical Device Regulation (MDR) and key changes
Session 2: Quality Management System update to meet MDR requirements
Session 3: Impact of EU MDR 2017/745 on Drug/Device Combination Products (DDCs)
Session 4: Clinical Evaluation of Medical Devices according to MDR
Session 5: Post Market Surveillance (PMS) & Periodic Safety Update Report (PSUR) requirements under the EU MDR
Dr Tina Amini
Division Director Medical Devices