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Tag : Medical Devices

12 Nov 2018

EU MDR Impact and Challenges – Q&A with Trey Thorsen.

The deadline for compliance with the European Union Medical Device Regulation (EU MDR) is fast approaching, which places its own challenges on companies who are under-staffed for such a large-scale transition. Additionally, 78% of medical device companies (according to recent reports) believe that they do not have the required understanding of new legislation in-house. So, what can medical device companies do at this critical time in the industry? Aside from improving their existing team’s knowledge, we’re seeing more and more […]

06 Apr 2018

Medical Devices: Deadlines are looming

If you are working within the Medical Devices industry you will understand it is going through a period of tremendous transformation; over the next six years we are facing several changes in legislation around the regulation of devices and the numerous deadlines to meet to ensure the products remain safe and compliant.   Firstly, it is important to understand the legislation which is affecting the Medical Devices industry: Almost every organization with a device on the market are now seeing […]