The latest news and updates from cognidox

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

The medical device development process is often broken down by experts into five distinct phases which all req...

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Organisational knowledge requirements in iso 9001:2015

The pursuit of quality in any company depends on your ability to transmit all kinds of organisational knowledg...

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Med Tech: where to start - Product development or document management?

What should come first in a med tech project? Product development or documentation? 

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Compliance Vs. Kaizen; how quality management can be part of your DNA

Companies working in heavily regulated sectors might have been historically slow to change and optimise their ...

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10 ways to screw up your business process mapping

Companies are often spurred to undertake business process mapping to improve their quality management.

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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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