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?

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June 20, 2018

[FEATURED] Substantial Drop In Certificates Withdrawn By EU Notified Bodies: Why Now?

Data from TEAM-NB, the EU notified body association, shows a big drop in withdrawn certificates from device firms. Does this signal an improvement in the quality of manufacturers’ submissions to notified bodies?

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October 4, 2017

What the FDA Reauthorization Act Means for Pharmaceuticals and Medical Devices

Signing document

On August 18th, President Trump signed the FDA Reauthorization Act (FDARA). Besides reauthorizing user fees for pharmaceuticals and medical devices for five years the law also focuses on many aspects of device regulation. (more…)

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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!