News Feed
[FEATURED] To What Extent Are Authorities Restricting Notified Body Activities?
How much do we know about what is happening in relation to unconfirmed reports that some European notified […]Read More[FEATURED] Medtech Tips: 7 Expert Pointers For A Successful Pre-Market Submission To US FDA
FDAer-turned-consultant Heather Rosecrans offers valuable tips for a successful submission, from avoiding sending a PMA or 510(k) to […]Read More[FEATURED] Commission’s Draft EU Standardization Request May Overwhelm Tech Committees At 11th Hour
A great many EU medtech standards may not be ready in time for manufacturers to demonstrate compliance with […]Read More[FEATURED] EU Regulatory Reads, June 2018: Experts Tell Industry To Get Moving Despite Shortfalls – Shift Later!
Pressure is building on companies to start compliance efforts to the EU Medical Device Regulation. But a good […]Read More[FEATURED] New Reasons Not To Use EU MDR’s Four-Year Extension, But Comply Earlier Or Retire Products Instead
The new EU Medical Device Regulation offers companies an option to market CE-marked devices for an extra four […]Read More