Common Mistakes Startups Make When Submitting to the US FDA
While medical device startups may have innovative ideas and technologies, they face significant hurd...
What is a 510(k)?
The United States Food and Drug Administration (FDA) regulates medical devices sold in the US throug...
Why FDA’s Cybersecurity Draft Guidance is a Controversial Change
On April 8, 2022, the FDA released an entirely new draft guidance for premarket medical device cyber...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
Do you wish to market your product in the EU? Well, things just got more complicated. Under the new ...
EUDAMED Timeline Update
On July 6th, 2022, the European Commission released an updated version of the EUDAMED timeline. This...
EUA Update: FDA Announces Intent to Withdraw Guidance
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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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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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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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A Look Back at the Emergency Use Authorization, and What Lies Ahead
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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 ...
