How Abbott Is Getting Their Digital House In Order



Getting Your Product Management Right for EU-MDR

EU-MDR is a major revision to the EU regulatory system – and arguably the most disruptive in over 20 years. The rules are changing for all CE-marked products. With no technical grandfathering, medical device makers must respond by May 2020. Otherwise, they might forfeit entry to new markets and existing market share.

Hear how Abbott, global leader in diagnostics, medical devices, nutrition and branded generic pharmaceuticals, transforms regulatory overhead into opportunity. Caroline Byrd, regulatory expert at Abbott and Michelle Boucher, Tech-Clarity explain how Abbott’s sustainable compliance program allows it to:

  • Make fact-based portfolio management decisions.
  • Recreate the “digital thread” required to demonstrate design control of products that are 5, 10 or even 40 years old.
  • Leverage and extend the value of its PLM investments.
  • Apply smart data management using a centralized – yet federated – approach.
  • Adopt a programmatic approach to future-proof submissions as regulations evolve.

Don’t miss this opportunity to hear two experts share a pragmatic, sustainable approach to EU-MDR compliance and product submissions. Use their advice, as your guide to selecting the best PLM solution to achieve similar goals for your organization.


Presenters

Michelle Boucher, Vice President of Research for Tech-Clarity

Caroline Byrd

 Caroline Byrd, Director of Regulatory, Abbott