The latest news and updates from cognidox

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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In praise of the Design Review Process

I worked in one of the large Cambridge-based technology consultancies for many years and was privileged to hav...

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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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Why your company should have a Quality Strategy

  I believe that a quality strategy is a vital element to the success of a business. Quality of product and op...

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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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11 myths about ISO 9001 - busted!

Mention ISO 9001 to most people, or tell them that you implement quality systems, and they'll start glazing ov...

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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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