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?

Do you like it?0
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.

Do you like it?0
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.

Do you like it?0
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.

Do you like it?0
December 30, 2018

[FEATURED] When Will EU Commission, Member States React To Calls For Extending Regulation Deadlines?

The EU medtech sector, seeing itself heading for a crisis, is hoping the authorities will imminently extend deadlines for the Medical Device and IVD Regulations. What more do we know after last week’s crucial Medical Device Coordination Group meeting?

Do you like it?0

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!