Links in the Chain: Economic Operators under MDR – Who They Are, What They Must Do… and Whether You Might Be One

Imagine that you’ve discovered a problem with a medical device – maybe something that makes the devi...

The Rise and Fall of the COVID-Era EUA: Why You’re Better Off with a 510(k)

Milk or dark chocolate? Paper or plastic? Mountains or the beach? EUA or 510(k)? The Emergency Us...

What is a 510(k)?

The FDA generally requires manufacturers to demonstrate that a new medical device is safe and effect...

Expanded Canadian Regulatory Amendments

In December 2018, Health Canada (HC) launched the Medical Device Action Plan (MDAP). The plan is in ...

Rise of the Machines: Regulating Medical Device Software

In the Terminator movies, the freakishly badass silver machines rebelled against their human creator...

The Wait is Over: What MDR Means for Your Legacy Medical Device

Unless you’ve spent the past few years marooned on a small and completely unconnected desert island,...

The Long and Winding Road: Regulatory Pathways for Vaccine Approvals

If the COVID-era emergency use authorization process has taught us anything, it’s that the standard,...

MDD to MDR – The Why, What and How of the Approaching Transition

The medical device industry is set to fully implement the much-anticipated EU Medical Device Regulat...

A Look Back at the Emergency Use Authorization, and What Lies Ahead

Despite advance warning and gloomy predictions, the eruption of the COVID-19 pandemic caught governm...

Tracy Eberly Discusses COVID-19’s Impact on Medical Device Companies

The COVID-19 health crisis has had a large impact on a plethora of sectors, with the medical device ...