Maetrics has over 34 years of experience in delivering compliance solutions for complex projects through times of regulatory change. Third party support for MDR, IVDR, CER, MDSAP, ISO 13485, and Supplier Quality Audits can deliver value and objectivity across these regulatory frameworks and our proprietary tools and training materials allow us to provide holistic service to our clients when required.
If you're looking to bring a medical product to market in Europe, Maetrics offers solutions across the whole MDR compliance support spectrum: from gap assessments for CE marked products, remediation, resubmission, product rationalization, quality system compliance, training and communication.
Maetrics offers a flexible, experienced, proven and proactive CER service which means we support compliance in multiple business areas for our clients. We can assess ALL devices, track when CERs need to be updated, actively monitor data, and amend CERs as new data comes to light to ensure your CERs are always up to date.
Drastic changes in product categorization for IVD devices mean a longer transition period as there will be more products to get ready for compliance. Maetrics can help ensure that you stay competitive - early compliance secures Notified Body certification and removes the risk of being held up at crucial stages in the compliance journey.
MDSAP & ISO 13485
For clients who require MDSAP or ISO 13485 compliance, Maetrics brings its portfolio of experience to provide tailored solutions. Proprietary processes allow us to work across multiple departments and sites to implement the standards consistently and efficiently, delivering process improvements and identifying and engaging with key stakeholders along the way.
SUPPLIER QUALITY AUDITS
Maetrics provides the entire spectrum of supplier quality management solutions, maintaining audit schedules and adhering to QMS targets for supplier management, giving your company a higher level of compliance and readiness for inspection.
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