The latest news and updates from cognidox

DHF, DMR and DHR. Demystifying FDA medical device development requirements

DHF, DMR, DHR…. to the uninitiated they might sound like out-of-town furniture stores or airport codes for exo...

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An A -Z of medical device development; acronyms, regulatory & technical terms

The regulations and literature surrounding medical device development are packed with acronyms and technical t...

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New IVD regulation is coming. are you ready?

From 2022 the In Vitro Diagnostics Regulation (IVDR) will require Notified Body intervention and review for 80...

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How to avoid the med tech graveyard with user centred design

A med tech device that has a poor user experience can be dangerous for consumers and commercially calamitous f...

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Why design controls matter in Medical Device Development

When it comes to medical device development, the absence of comprehensive design and development documentation...

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Are you developing a medical device?

Are you developing a medical device? And are you certain about that? It might sound like a crazy question. If ...

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What is 21 CFR Part 11? FDA requirements explained

WTH is FDA 21 CFR Part 11? That’s a question many medical device developers considering entering the US market...

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