The latest news and updates from cognidox

What are good documentation practices & how can they best be implemented?

Good documentation practices (also known as GdocP or GDP) are standards for document management and control th...

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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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How to talk to the fda

I am a former FDA staff member and now back in the private sector. If you are in Regulatory Affairs, you are i...

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