The latest news and updates from cognidox

Why not just use Google Drive as a document management system?

Google Drive is a cloud-based program that allows you to create, edit, store, and share documents. Many busine...

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QMS documentation requirements in ISO 13485

How should you structure your documentation to meet the requirements of ISO 13485?

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What is document lifecycle management & why does it matter?

What are the 7 stages of the document lifecycle?  Why is managing and controlling the lifecycle a critical par...

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Take it from me: your medical device start-up needs a Lean eQMS

In this blog, Shaun Knights, Head of Quality at period care company Callaly, tells us why his start-up needed ...

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Corrective actions: why, when and how?

It’s the job of your corrective action process to identify and eliminate the systemic issues that will prevent...

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Document control in your medical device Quality Management System

Document controls are a fundamental requirement of every medical device regulatory regime. They are the ‘build...

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How to stop ‘over-processing’ in your medical device QMS

Building a quality management system is never a quick and simple process. But in medical device development, w...

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What is a UK Responsible Person (according to the MHRA)?

Following Britain’s exit from the EU, all non-UK medical device and IVD manufacturers who want to place their ...

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Understanding the regulation: challenges for UK IVD device developers

IVD device regulation is about upping the bar—it’s about making products to a higher standard and ensuring the...

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