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.
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