Develop Real Capability

Making the best use of the FDA Inspectio...

Our Life Sciences industry expert Tutor, Gerry Burke, makes some suggestions as to how Medical Device, Pharma and Biopharma manufacturers can make the best use ...

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Understanding the Software Validation Re...

With the transition of many medical device companies to ISO 13485:2016 “Medical Devices – Quality Management Systems – Requirements for regulatory purpose...

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