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John Henchion

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Are You Ready? Major Changes Coming to Europe MDR and IVDR

By John Henchion, September 28, 2017

Introduction: One of the major focuses this year at the RAPs Convergence in DC was implementation timelines for the EU Medical Device Directive and the In Vitro Device Regulations.

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Where to Draw the Line?

By John Henchion, September 11, 2017

What is an appropriate level of GMPs for a supplier manufacturing site?

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How to Understand ASTM E2500