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6 Reasons why Benefit-Risk Analysis is required for Individual Risks under the MDR

Written by Expert Tutor and Industry Expert John Lafftery in response to his post on “What is the Difference between the EN and ISO versions of 14971:2019 Part 2?” The following query came from a reader; “Where does it say in the MDR that benefit-risk analysis i...

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Setting Up the Spellchecker in Microsoft Word – Video Tutorial

Our expert Technical Writing Tutor, John Lafferty, gives a useful tutorial on Setting up the Spellchecker in Microsoft Word.  If you are having trouble writing technical memos, reports or documents, our comprehensive Technical Writing training course be may of interest to you. T...

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What is the difference between the EN and ISO versions of 14971:2019? Part 2

What is the difference between the EN and ISO versions of 14971:2019? Part 2. Following on from our Expert Tutor John Lafferty’s previous blog which explored the difference between EN and ISO versions of 14971:2019 – Part 1, and based on feedback received, it is appar...

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The Software Validation Requirements of ISO 13485:2016 Explained

With the recent 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 fulfill i...

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What is the difference between the EN and ISO versions of 14971:2019

EN ISO 14971:2019 Medical devices – Application of risk management was published in January 2020, but how does the EN version differ from the ISO version and what are the implications for the Medical Device manufacturer? Our Expert Tutor John Lafferty highlights that key differ...

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