Industry News

EUA Update: FDA Announces Intent to Withdraw Guidance

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Common Mistakes Startups Make When Submitting to the US FDA

BusinessUncategorized

PRESS RELEASE: Time is Running Out: All MDD Certificates Expire May 26, 2024

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Fang Consulting No. 102 on Inc. Magazine’s List of Fastest-Growing Private Companies

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What to Know About De Novo

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What is a 510(k)?

EU MDR

Public Health Emergency Expiring: What Will Happen to EUA’s?

Industry News

Why FDA’s Cybersecurity Draft Guidance is a Controversial Change

EU MDRIndustry News

Post Market Clinical Follow-Up Under EU MDR

EU MDRIndustry News

EUDAMED Timeline Update

Industry News

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

EU MDR

MDR NB Common Submission Issues and How to Prevent Them

Company News

Questions and Answers With Maddie

Industry News

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

Industry News

What is a 510(k)?

Industry News

Expanded Canadian Regulatory Amendments

Industry News

Rise of the Machines: Regulating Medical Device Software

Products

Medical Devices, Medicinal Substances – and Memorex

EU MDR

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

Products

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