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Our objective is to provide you with accurate and reliable test reports that can be submitted to meet global regulatory requirements, including FDA and CE marketing approval. The types of components that we test is limitless and our medical device testing scope is one of the largest under ISO/IEC 17025 : 2017.
Our team will guide you through the evolving path of achieving regulatory clearance, the first time. With Empirical, you will receive comprehensive, trusted regulatory consulting that you be confident in. We provide all regulatory support, including review, deficiency response, & compilation.
The European Medical Device Regulation (MDR) is a new set of regulations that governs the production and distribution of medical devices in Europe, and compliance with the regulation is mandatory for medical device companies that want to sell their products in the European marketplace.
Empirical Technologies Corp. is the leading medical device testing lab for orthopedic medical devices. We also have the largest scope of testing standards in the industry. Our proven expertise in many biomechanical engineering disciplines and our philosophy of continuous improvement in all that we do enables us to be the best.