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...

Stay Calm and Carry On: What Brexit Means for Your Medical Device

Much has been said about the fast-approaching transition to the Medical Device Regulation (MDR) in E...

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...

Is Your Product a Medical Device? The Devil is in the Details.

As a medical device manufacturer, how do you know if your product is a medical device? Unfortunately...

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 ...

Tracy Eberly and Fang Consulting Discuss Choosing the Best Firm for Your Needs

In a field as innovative and diverse as the medical device industry, finding the right consulting fi...

Growth

By 2020 Europe will be moving from MDD to MDR resulting in stricter guidelines for companies dis...

Escape Room – Escaped!

Every few months at Fang, we take an afternoon off to gather as a team and participate in the gr...

Notified Bodies

With the EU MDR (2017/745) replacing the current MDD (93/42/EEC) in the EU, many changes are on ...