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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March 18, 2019

[FEATURED] Notified Bodies And EU Industry Voice Separate, But Aligned Frustrations Over Slow Progress In NB Designations

Notified body and medtech industry trade associations both issued formal statements pointing out that delays in designating notified bodies are the biggest barrier to products being able to comply with the new EU Medical Device Regulation before deadlines. Time is running out.

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February 16, 2019

[FEATURED] EU Regulatory Roundup, 2018: Year Of Dithering And Distractions Likely To Be Topped By Upcoming Year Of Turbulence And Stress

2018 needed to be medtech’s year to focus on the ongoing implementation of the EU MDR and the IVDR and the structures and documents to support them.  But lack of progress means a 2019 work bulge amid Brexit issues and recent journalistic investigations. Here’s a look at the top EU regulation issues and articles of the past year.

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February 4, 2019

[FEATURED] Complying On Time With MDR/IVDR: What Options Are Open To Those In Trouble?

Manufacturers who have not managed to transfer their certificates from a UK notified body prior to Brexit, or who have not obtained certificates under the EU Medical Device or IVD Regulations in time, can not expect to receive a sympathetic hearing from the EU Commission. In an interview with Medtech Insight, Lawyer Alison Dennis examines options for medtech firms.

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January 23, 2019

[FEATURED] Two EU Notified Body Frontrunners In Race For Designation Under New Regulations

The latest revelations in London and Brussels over the last week show concrete progress is being made toward the designation of notified bodies. But which organizations will be named first and when?

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RAPS Regulatory Convergence 2019

September 21-24, 2019

Philadelphia, PA

Register today to examine regulatory challenges and solutions with top industry professionals.

Book a consultation with us! President Laurie Mitchell and CEO Lalitha Jonnavithula will be taking meetings at booth #349. 

Stop by for exclusive assets, tips, or to discuss regulatory or medical writing projects. And while you’re there… sign up for the chance to win a FREE Amazon Echo!