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Joe Byrne

Recent Posts

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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An A -Z of medical device development; acronyms, regulatory & technical terms

The regulations and literature surrounding medical device development are packed with acronyms and technical t...

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5 critical success factors for a new product development process

A responsive new product development (NPD) process has always been a key part of a high tech business strategy...

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How's your Quality Management - Ad hoc, analytical or chaordic?

How can you help your business evolve its mindset to achieve the most instinctive, frictionless and effective ...

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Document Control requirements in ISO 9001:2015; what you need to know

Document control is a key part of any Quality Management System (QMS) and, therefore, a requirement of ISO 900...

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