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Is Analysis of Multiple-Fault Conditions a Requirement of ISO14971?

The above question was posed by one of the delegates at a recent Quality Risk Management and ISO 14971:2019 virtual training course delivered by our expert Tutor John Lafferty John reviews the requirements for Single-fault and Multiple-Fault conditions in ISO 14971, the EU MDR/IV...

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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

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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7 Elements of a Good Technical Document

Technical Writing – what makes a good document? A good document is one that gives a clear message which all of the intended readers can easily understand. Key elements of a Technical Document: The document must convey the most important message and direct the reader to any...

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