The latest news and updates from cognidox

How to develop a medical device; the 5 phases of med-tech development

The medical device development process is often broken down by experts into five distinct phases which all req...

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Med Tech: where to start - Product development or document management?

What should come first in a med tech project? Product development or documentation? 

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MDSW, IVDR, MDR and the new guidance from the EU

As the 2020 deadline for compliance with the EU’s new Medical Device Regulation (MDR) fast approaches, the EC’...

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GAMP 5 ®: How to take a risk-based approach to GxP computerised systems

The Good Automated Manufacturing Practice (GAMP 5 ®) guidelines define a set of core principles for GxP, as pr...

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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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