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As we move into 2024, the Life Sciences sector in Europe and the UK continues to face a dynamic and challenging regulatory environment. The EU Medical Device Regulation (MDR), effective since May 26, 2021, and the ongoing impacts of Brexit, the United Kingdom’s 2020 exit from the European Union, remain central issues. These changes are […]

Medical device manufacturers (MDMs) have various resources to ensure compliance with the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). Recently, the EU extended these deadlines, giving manufacturers more time for compliance. For instance, conformity assessments for higher-risk devices (class IIb and class III) are now due in 2027, while lower-risk devices […]

With its 30% share, Europe is a big player in the medical devices market. European regulations controlling manufacturing, marketing and usage of the medical devices, also controls the language requirements for the medical devices that will be sold in the European Union. Since its first introduction in the 1990’s, one of the important consequences of […]

With the deadline for the implementation of the new Medical Device Regulation (2017/745) approaching, many life sciences companies, in particularly medical device manufacturers are in preparation mode. Executing a current state-analysis is the first step, but many companies are still unsure about what it is that’s changing and to what extent these changes will affect […]

In September, Shannon Rose Farrell, Life Sciences Localization Thought Leader and US Managing Director and Sarah LaFave, Life Sciences Operations Director will be heading to Phoenix, AZ for the 5th Semi-Annual Medical Device Labeling & Packaging Conference. Held bi-annually, the Medical Device Labeling & Packaging Conference focuses on different aspects affecting medical device and diagnostic […]