June 13, 2019

EU Officially Designates Second Notified Body Under The MDR: TÜV SÜD Enters Center Stage

TÜV SÜD, headquartered in Germany, is the second notified body to be officially designated under the EU MDR. Is this good news going to significantly lessen medtech industry’s concerns over delays in accessing the new, tougher regulatory system for medical technology, with time running seriously short?

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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!