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The Post-Market Gambit

After EU MDR and IVDR comes a game of chess with billions of Euros at stake

Mounting compliance costs could exceed 5% of annual revenue, presenting MedTech companies with a difficult decision:

    • Whether to embrace compliance as a continuous process, including making substantial changes to the Quality Management System (QMS) and investing in agile technologies to eliminate data bottlenecks and streamline workflows.
    • Or, struggle to keep pace in the new EU Regulatory landscape, relying on outdated data systems and time-consuming manual workflows.

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