Event info
Date:11 Mar
Time:15:00 - 16:00
Venue:Online
Contact person
Nicole Mastrell

Nicole Mastrell

Event Manager & PA to CEO

nm@mva.org

+45 6141 8634

Post Market Surveillance (PMS) & Periodic Safety Update Report (PSUR) requirements under the EU MDR

Are you ready for the EU Medical Device Regulation

The deadline for the EU Medical Device Regulation (MDR) 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.

The NDA team, led by Dr Tina Amini has identified several hurdles accompanying the new MDR 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 addressing each hurdle in turn.

Webinar summary

Session 1 (Jan 14th): Introduction to EU Medical Device Regulation (MDR) and key changes

Session 2 (Jan 28th): Quality Management System update to meet MDR requirements

Session 3 (Feb 11th): Impact of EU MDR 2017/745 on Drug/Device Combination Products (DDCs)

Session 4 (Feb 25th): Clinical Evaluation of Medical Devices according to MDR

Session 5 (Mar 11th): Post Market Surveillance (PMS) & Periodic Safety Update Report (PSUR) requirements under the EU MDR

You can choose to attend one or more of the webinars.

 

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