The latest news and updates from cognidox

How can you get your FDA 510(k) submission right first time?

Developers who want to release a medical device in the US need to seek permission from the FDA. Depending on t...

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What is a document control system and why is it important?

Having a document control system in place is a requirement of quality standards and regulations around the wor...

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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 exot...

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Should you use Microsoft software to build your own digital QMS?

SMEs creating a digital Quality Management System (QMS) will often reach for the most familiar tools to build ...

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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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CBD, GMP and GdocP; quality management in the cannabis industry

Around the world different rules apply for the cultivation, manufacture and sale of cannabis and CBD products....

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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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