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Medical Devices (Global)

Global Regulatory Services (GRS) has several specialist medical device teams and individuals who can support and guide you through the appropriate regulatory pathways to market no matter where your company is located or in which territory you wish to launch.  Currently, America and Europe are popular destinations but increasingly we are assisting companies to launch into China and Japan as well.

The key message, however, is that medical device guidelines and regulations are changing globally.  GRS is closely monitoring these changes and is able to provide support during current and future transition phases to ensure compliance. 

Clinical Evaluation (including clinical trials) will be critical to the success of your medical device product.  For a guide on what changes may be happening in Europe, please click here for a copy of a presentation given by Greer Deal, Director of GRS, at the M11 MedTech Forum in October 2013 entitled “Will the new EU Medical Device Regulation mean more trials at more cost but more reward?”

Please contact us with your specific regulatory compliance requirements.