The New EU Medical Device Regulation (2017-745) - Mandatory 26-May-2021


Juan M. Campos is a keynote Speaker at Compliance Key. Juan M. Campos is a Medical Device professional with 32+ years of continued industry experience.His main areas of expertise include Quality Assurance, Regulatory Compliance and RegulatoryAffairs. He has led culturally and geographically diverse QA/RA teams in Spain, UK, France,Switzerland, Netherlands, Germany, Portugal, Italy, Greece and Turkey directly reporting to him.Additionally he has successfully coordinated global QA/RA projects with extended on site presence in USA and China.Most of the Regulations that govern today's Medical Devi........

Overview

This webinar will discuss main differences between current EU Medical Device Directive (MDD) 93/42/EEC and new EU Medical Device Regulation (MDR) 2017-745 and how to ensure compliance with the new MDR requirements that will be mandatory starting 26-May-2021.

Why should you attend this webinar?

Only medical device companies that are in compliance with the new Medical Device Regulation (MDR) 2017-745 will stay in the European market after 26-May-2021. It's key to understand the gaps with the previous Medical Device Directive (MDD) 93/42/EEC and how to remediate them to continue business in the 2nd (about 30 % worldwide volume) worldwide medical device market.

Areas Covered in the Session:

  • Device classification
  • Conformity routes
  • General Safety and Performance Requirements (GSPRs)
  • Technical documentation
  • Post market surveillance (PMS)
  • Clinical evaluation
  • UDI
  • EUDAMED
  • Economic operators

Who can Benefit:

  • Quality Assurance Managers / Directors / VPs
  • Regulatory Compliance Managers / Directors /VPs
  • Regulatory Affairs Managers / Directors / VPs
  • Clinical Managers / Directors / VPs


Webinar Id: CKJMC001

Training Options:

Duration: 60 mins

  08-Jun-2020

 10:00 AM PT | 01:00 PM ET

 Single Attendee: [Only for one participant]

$129 (Live)                    $239 (Live + Recorded)

 Multiple Attendee: [For a group of 2-5 participants]

$323 (Live)                    $637 (Live + Recorded)

 Corporate Attendee: [For a group of 6-10 Participants]

$656 (Live)                    $1020 (Live + Recorded)

 Recorded: [Six month unlimited access]

$179 (Single Attendee) $379 (Unlimited Attendee)

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