In the meantime, please feel free to browse our service offerings below.
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.
