The latest news and updates from cognidox

Joe Byrne

Recent Posts

Life after Covid-19 for the IVD (in vitro diagnostics) industry

The Covid pandemic has brought new attention, investment and competition to the IVD sector. But with new oppor...

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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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8 GMP principles for med tech developers to live by

Good Manufacturing Practices (GMP) are intended to ensure that pharmaceutical products, medical devices and ot...

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4 ways to build a medical device quality management system

Are you facing an urgent need to build a Quality Management System (QMS) for your medical device? Do you need ...

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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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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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Why your QMS needs to be an eQMS

If you want to develop a Quality Management System that meets the regulation and powers your commercial succes...

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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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