Strategies for Overcoming the Biggest Challenges in Achieving IVDR Compliance

Please join us on July 27, 2021 for our latest webinar, addressing the urgency of the IVDR. The IVDR date of application is May 26, 2022, less than a year away.

Notified bodies (NBs) are currently predicting certification timelines of at least 7-12 months, and these will get longer as they get busier. 

We will cover strategies for overcoming the biggest challenges in achieving IVDR compliance, including:

  • Notified bodies
  • Classifications
  • Economic operators
  • Quality management systems
  • Post-market surveillance
  • Training
  • Balancing risks
  • And much more

Presenters:

Kristen Meany, MS, CQA, RAC (U.S., EU)

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  • 20 years leading global regulatory teams
  • Knowledge of regulatory strategy and all type of submissions
  • Diverse product knowledge of medical devices and IVDs
  • Experience negotiating with regulatory bodies

 


Felicia Hosey, RAC

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  • 15 years in new product development research and regulatory consulting
  • Experience with global medical device regulations
  • Work with tool and template development for MDR and IVDR

 


Ashley (Ash) Clark, MS, RAC

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  • 8 years in pre- and post-market regulatory roles
  • Experience with MDR and IVR remediation support
  • Focus on the impact of Brexit on MDR and IVDR implementation
  • Expertise in providing strategic solutions for IVDR compliance

Fill out the form to register to attend the IVDR webinar.