EUA Update: FDA Announces Intent to Withdraw Guidance

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Why FDA’s Cybersecurity Draft Guidance is a Controversial Change

On April 8, 2022, the FDA released an entirely new draft guidance for premarket medical device cyber...

Post Market Clinical Follow-Up Under EU MDR

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EUDAMED Timeline Update

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

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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)

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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

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Medical Devices, Medicinal Substances – and Memorex

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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?

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

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The Long and Winding Road: Regulatory Pathways for Vaccine Approvals

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

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

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

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

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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 ...