Assessing Organizational Readiness for EU MDR OnDemand Webinar

Presenting “Assessing Organizational Readiness for EU MDR” are industry experts Richard Houlihan, CEO of Eudamed.eu, a leading consultant and international speaker on MDR technical management, and Stephanie McArdle, Vice President of AssurX’s Life Sciences Product Management.

In this webinar, they will discuss how medical device manufacturers and companies that distribute devices and/or drug delivery systems to European Union member countries will experience an organizational shift once EU MDR is fully implemented in May 2020.

They will explore how this shift goes beyond just the Quality and Compliance departments and why organizational readiness is critical for maintaining current products in the marketplace and getting them to the market.

Key focus areas include:

  • What changes to expect with EU MDR and how to plan for recertification
  • Where technical quality, compliance, and IT systems intersect and how to bring them together to ensure continuity and compliance
  • Why the management of data will make or break your submission to EUDAMED
  • What we know about EU MDR and the revamp of the EU Medical Device Directives to date
  • Impact of quality standards and design control from R&D through post commercialization
  • The registration process with EUDAMED and bringing together disparate data sources

Download the AssurX EU MDR Solution Brochure

The AssurX EU MDR solution aligns business logic with the most up-to-date MIR template published by the European Commission (EC) and automates the documentation and submission under vigilance guidelines and reporting time frames.

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