Medical Device Regulation 2017/745 (MDR) - Free QAdvis Breakfast Seminar in...

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Location

Kista Entré Konferens

7 Knarrarnäsgatan

164 40 Kista

Sweden

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Event description

Description

Medical Device Regulation 2017/745 (MDR) – Prepare your organization for an efficient transition from MDD to MDR

Welcome to this free breakfast seminar, where you will learn more about the impact and implications of MDR, which applies for all medical device manufacturers from 26 May 2020. That date being less than a year away, and implementation being both time consuming and complex, keeping updated and moving forward is crucial.

In this seminar, we will discuss the following:

  • What is going on at the moment regarding the new IVDR and MDR regulations

  • The current status of IVDR and MDR implementation at Notified Bodies and Competent Authorities

  • The new requirements at a glance – what are the main differences between MDD and MDR?

    • Classification rules

    • The certification process

    • General Safety and Performance Requirements (GSPR)

    • Technical documentation

    • Clinical evaluation

    • Eudamed

    • UDI

    • Post-Market Surveillance

  • MDR implementation timeline

The presentation will be held in Swedish, with material in English.

Speakers

This seminar will be presented by experienced QAdvis consultants.

Note:

The event is free but space is limited – register to participate. If you register but don’t show up, you will be charged 300 SEK.

Date and Time

Location

Kista Entré Konferens

7 Knarrarnäsgatan

164 40 Kista

Sweden

View Map

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