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[FEATURED] FDA Guidance Looks At Benefit Vs. Risk In Certain 510(k)s
A newly finalized guidance document from US FDA explains how the agency will evaluate benefit and risk questions […]Read More[FEATURED] First EU Notified Body Designations Could Come Earlier Than Expected, But Caution Advised
There’s been progress toward designating notified bodies against the EU’s medtech regulations, but the developments need to be […]Read More[FEATURED] EU Post-Market Clinical Follow Up: What Manufacturers Need To Know
The EU’s new medtech regulations introduce much more comprehensive post-market clinical follow-up requirements for device and diagnostics companies. […]Read More[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