Category Archives: Life Sciences

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Making the best use of the FDA Inspections Pause

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 the ongoing pause in FDA Inspections. The FDA has stated that it has ‘no plans to resume foreign inspections for opera...

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Understanding the Software Validation Requirements of ISO 13485:2016

With the transition of many medical device companies to ISO 13485:2016 “Medical Devices – Quality Management Systems – Requirements for regulatory purposes”, it is a challenge for the industry to obtain suitably qualified software validation engineers to fulfil its requir...

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IVD Manufacturers counting down to compliance and the new EU Regulations

IVD Manufacturers: Will you be Compliant with the new EU Regulation 2017/746 when it comes into effect on IVDR by May 2022? Updated insights from our expert Tutor in Medical Devices John Lafferty As we all know, EU Regulation 2017/746 on In-Vitro Diagnostic Devices (IVDR) comes i...

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Uncertainty of a Different Kind….Estimation of Measurement Uncertainty in Testing Labs

Uncertainty was one word used time and time again during the pandemic. Each of us have different approaches for trying to deal with expected change or apprehension about what lies ahead. I am certainly hopeful of brighter days ahead…This article, written by our Expert Tutor, An...

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Top Tips for a Better Virtual Training Experience

After moving from years of classroom based training to the virtual world, our Expert Tutor, Edel Jones asks the question is virtual training here to stay and gives valuable insights and advice on how to make the most of virtual As ISO 22000/2018 defines Risk as ‘The effect of u...

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