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- Or, struggle to keep pace in the new EU Regulatory landscape, relying on outdated data systems and time-consuming manual workflows.