The latest news and updates from cognidox

What kind of Product Management Process do you need?

How do you need your product management process to function? A classic article in the HBR got us thinking abou...

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What are good documentation practices & how can they best be implemented?

Good documentation practices (also known as GdocP or GDP) are standards for document management and control th...

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MDSW, IVDR, MDR and the new guidance from the EU

As the 2020 deadline for compliance with the EU’s new Medical Device Regulation (MDR) fast approaches, the EC’...

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GAMP 5 ®: How to take a risk-based approach to GxP computerised systems

The Good Automated Manufacturing Practice (GAMP 5 ®) guidelines define a set of core principles for GxP, as pr...

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ISO 27001 and ISO 9001: How an integrated response can work

Many high tech businesses who are implementing a Quality Management System (QMS) to gain ISO 9001:2015, are in...

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NASA & the bra makers; quality management in the space race

In 1969 quality management was truly the final frontier in the space race. As NASA engineers developed unique ...

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DHF, DMR and DHR. Demystifying FDA medical device development requirements

DHF, DMR, DHR…. to the uninitiated they might sound like out-of-town furniture stores or airport codes for exo...

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What does a good change control process look like?

A change control process is a vital part of any product development and management function. But if it’s not e...

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ISO 26262: How can DMS solutions support the development of driverless tech?

Advanced Driver Assistance Systems (ADAS) and even driverless cars, once the stuff of science fiction, are rap...

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