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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Implementing Medical Device Design Controls for ISO 13485 and FDA 21 CFR 820

30 years ago the FDA introduced robust new requirements for medical device design control following a string o...

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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 wanting to access the US market mu...

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A 21 CFR Part 11 checklist: 7 key FDA e-signature requirements

How does your organisation authorise, authenticate, document and police the use of electronic signatures withi...

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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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Bionic pigs are not enough. How to win med-tech investment if you're not Elon Musk

When Elon Musk unveiled his ‘bionic pig’ in an on-line event in September there was much hype and more than a ...

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QSR Compliance: What’s inside FDA 21 CFR Part 820?

The FDA’s Quality System Regulation (QSR) for medical device manufacturers is commonly known as FDA 21 CFR Par...

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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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Digital Signatures: New MHRA guide clarifies remote approval requirements

A lot of us have been challenged by remote working lately, whether it’s the back ache acquired from working on...

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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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Why the FDA want Proactive Quality Management Systems

Reports from the U.S. tell us the FDA is continuing to prioritise Proactive Quality Management in the medical ...

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How digital signatures can help secure regulatory compliance

Digital signatures are proving valuable tools for businesses developing products for release in highly regulat...

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