September 12, 2019

[FEATURED] Global Call To Rethink MDR Timing Sees Commission Dig Heels In Further

The calls for a delay in the implementation of the new EU MDR are becoming increasingly loud on the international front, with the US, for one, wanting to see a three-year postponement. Is the European Commission right to remain stubbornly attached to its deadline?

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March 1, 2019

[FEATURED] 33-Country Single Market For MDR And IVDR, And Bigger Reach Beyond

More often than not, the new EU Medical Device and IVD Regulations are talked about in the context of the 28 countries of the European Union (including the UK, for now). In reality, the regulations will have a much wider reach and influence, with Australia making particular efforts to align with the EU.

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Generis American Medical Device Summit 2019

Oct 28-29, in Chicago, IL

Join our President Laurie Mitchell at the AMD summit as she leads a session on day 2: Systematic Literature Review: How to Empower Data-Driven Decision Making.

Interested in discussing regulatory or medical writing projects? Book a free consultation with President Laurie Mitchell and CEO Lalitha Jonnavithula at booth #13, where you can sign up for the chance to win a FREE Amazon Echo!