The latest news and updates from cognidox

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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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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EU IVDR (In Vitro Diagnostics Regulation): Time’s running out to comply

The EU In Vitro Diagnostics Regulation (IVDR), written in 2017, was developed to replace the existing EU In Vi...

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What's the best document control software for ISO 9001 & ISO 13485?

There’s plenty of document management and file-sharing software available on the market, but not all of it is ...

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What are the FDA's requirements for CAPA (Corrective and Preventive Action)

Having a repeatable procedure for Corrective and Preventive Action (CAPA) is a key FDA requirement for medical...

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Compiling a design & development plan for your medical device

What are the planning requirements for a medical device design and development process? And what tools can hel...

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Process verification vs process validation for medical devices

Process verification and validation should be a key part of a medical device manufacturer’s QMS. But what’s th...

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