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Joe Byrne

Recent Posts

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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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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7 Quality Management Principles of ISO 9001:2015 and how to live by them

ISO 9001:2015 and its related quality standards are all based on the ‘Seven Quality Management Principles’ def...

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4 steps to build a simple & effective supplier quality management system

Supplier management needs to be a collaborative and proactive process if it’s going to deepen key relationship...

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Document Control requirements in ISO 9001:2015; what you need to know

Document control is a key part of any Quality Management System (QMS) and, therefore, a requirement of ISO 900...

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

    The medical device development process is typically broken down into five distinct phases.  Each one requi...

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