In this new research paper, Maetrics details the $16.5BN competitive market advantage for medtech firms that move quickly to comply with the new European Medical Device Regulation (MDR).
The MDR is designed to improve both clinical safety and fair market access for all medtech players, but a rapidly emerging capacity shortage both among Notified Bodies – tasked with certification – and expert compliance staff and consultants, means that manufacturers may find themselves unable to complete compliance across their product portfolios by the statutory deadline if they delay their preparations.
Maetrics has longstanding experience applying new and complex standards consistently and efficiently while developing compliance strategies critical to your company’s success. Our third party support for MDR, IVDR, MDSAP, ISO 13485, and Supplier Quality Audits can deliver value and objectivity across the whole review and implementation process.
Founded in 1984, Maetrics is a global life sciences consulting firm focused exclusively on regulatory, quality and compliance solutions for Medical Device, Diagnostic, Pharmaceutical and Biotechnology companies.