August 29, 2019

[FEATURED] EU MDR: Handful Of Additional Notified Body Designations Await Go-Ahead

Recent indications from the European Commission led EU medtech stakeholders to believe that more notified bodies would have been designated by now. Not so, and the lack of any visible progress means that, for manufacturers, nerves will start to jangle again before long.

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July 25, 2019

[FEATURED] Brexit Delay Gives EU27 Yet More Time To Grow Number Of EU-Compliant Devices

Has the European Commission done enough to allow UK-certified medical devices to continue on the EU27 market in the event of the UK dropping out of the EU without a deal – a possibility that remains very real?

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July 2, 2019

[FEATURED] Notified Body Q&A: 3 NBs Talk EU MDR Enforcement, The IVDR ‘Big Bomb,’ ‘Tough’ Regulators – And More Insights

MEDCERT’s Klaus-Dieter Ziel, TÜV SÜD Product Service’s Bassil Akra and Qserve Group’s Gert Bos answered questions about the EU’s new Medical Device and In Vitro Diagnostic Regulations at MedCon 2019.

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April 23, 2019

[FEATRURED] One In Three Medtech Innovators Will Be ‘Driven Out Of Business’ By EU MDR, German Business Survey Finds

The EU Medical Device Regulation is 15 months away from being implemented in full, and a new German survey about its potential impact on the medtech innovation and patient-care landscape makes for sobering reading.

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RAPS Regulatory Convergence 2019

September 21-24, 2019 in Philadelphia, PA

Interested in discussing regulatory or medical writing projects? President Laurie Mitchell and CEO Lalitha Jonnavithula will be taking meetings at booth #439 at RAPS 2019.

Book a consultation with us for exclusive tips, assets and more. Stop by the booth and sign up for the chance to win a FREE Amazon Echo!