FDA News Webinar: Don't Fall Behind on 2021 MDR Updates
How to Prepare for New US & European Requirements

The FDA and the European Union have announced changes to their medical device reporting (MDR) standards, which go into effect February 2021 and May 2022, respectively. In order to remain compliant, avoid fines and continue to do business in the US and EU without penalty, you and your team should fully understand how to comply with these changes. Are you fully prepared for the new MDR regulations?

To ensure that you are fully prepared and informed on the best way to prepare for the upcoming MDR changes,  join your industry peers as ETQ guides you through the updated medical device reporting expectations, including ways to harmonize your regulation management strategies across multiple countries and territories.

Webinar Takeaways:

  • Global harmonization trends and the overall direction for eMDR and EUDAMED
  • The EUDAMED-prescribed phase approach to releasing six modules (actors, UDI devices, certificates and notified bodies, vigilance, clinical investigation and post-market surveillance), along with target timelines
  • Three data upload strategies for EUDAMED reporting: web-based form, bulk upload via web form and machine-to-machine automated
  • Tools that can help your processes adjust automatically with less error
  • Industry moves toward combination product and their impact
  • The significance of the FDA going public with patient public codes
  • The harmonization of international reporting terminology, especially around adverse events, country and country codes
  • The vision and roadmap to navigating the next 3 to 5 years of regulations

michelMichel Moravia, Product Manager, Quality, ETQ is a Quality Leader and Engineering Professional with over 10-years of experience in the Biotech/ Medical Device industry. His expertise spans from New Product Introduction, Quality Control/Quality Assurance, and Technology & Manufacturing Transfer. He has also served as a Leader for PSP Courses and Kaizens for Danaher Corporation. He is a certified BSI ISO 13485: 2016 Lead Auditor. Michel holds a Masters of Science in Product Design Engineering and an MBA from Boston University.

tom barlowTom Barlow, Strategic Solutions Engineer, ETQ has over twenty-five years of experience working in Quality. He began his career as a Quality Systems Manager, where he documented and implemented all aspects of a QMS that ultimately achieved ISO 9001 registration. Having caught the "quality bug", Tom then consulted with numerous companies to help streamline their Quality Management Systems, ultimately achieving compliance.  Tom was drawn to ETQ almost 18 years ago when he discovered the power of ETQ Reliance. With its unparalleled configuration capability, he realized that ETQ Reliance was the perfect tool to automate any organization's compliance management system. Since joining ETQ in 2003, Tom has served in various sales and solutions engineering roles and has been instrumental in contributing to the organization's growth.

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