No longer directives, but laws that enforce penalties, the European Union Medical Device Regulation (EU MDR) and In Vitro Diagnostic Regulation (EU IVDR) will increase the scope and stringency of compliance dramatically. To minimize exposure, you need an expert partner to ensure your compliance readiness. Why Validant?
While the COVID-19 crisis has driven the European Commission to push back the date for MDR to take effect by one year, there are significant changes in clinical evaluation, risk management, general safety and performance requirements (GSPR), supplier/economic operator control, labeling, post-market surveillance, vigilance, and other related processes that manufacturers must address immediately in order to meet even this extended deadline.
Validant employs a proven methodology focused on both rapid execution and empowering your internal quality and regulatory departments to sustain compliant processes. Services include:
Validant’s team has helped multiple medical device clients, from start-ups to top 30 leaders, implement a sustainable approach to EU MDR and IVDR compliance.
Whether you need a turnkey solution to develop and executea complete, compliant regulatory strategy or additionalexpertise to tackle specific complexities like periodic safetyupdate reports (PSURs) or clinical evaluation reports (CERs),Validant will deliver the expert resources you need, whenand where you need them.
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Manufacturers at all stages of readiness have benefited from our proven methodology to achieve compliance.
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