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...

MDR NB Common Submission Issues and How to Prevent Them

Fang’s internal processes and checklists have evolved over the last 3 years since we started working...

Questions and Answers With Maddie

If you’ve been to the office or seen the back of one of our business cards, you know that Maddie Ebe...

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...

Medical Devices, Medicinal Substances – and Memorex

Is it a drug or a medical device? Or both? The old “Is it Live or Is it Memorex?” commercials fro...

Class I Devices Under MDR: To NB, Or Not To NB?

Note: The following discussion applies to non-custom, non-investigational medical devices. If you...

How Do I Know if My Software is a Medical Device?

As our world becomes ever more digitized, software has begun to infiltrate every minute of our day. ...

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...

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 ...