Category Archives: Life Sciences

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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 Exert 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 appare...

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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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Tech Writing Tip – Writing Style

Writing Style Tailor your writing style for your intended reader to make your document more effective and easier to understand. Always bear in mind the technical level of the reader when writing your document. Use formal rather than informal language; for example, use the word c...

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ISO 14971 is Changing

“ISO 14971 is Changing’’ As many of you may know already, ISO 14971 is changing yet again! Changes to ISO 14971  The new standard will be known as ISO 14971: 2019. The most significant changes will be that most of the guidance currently contained in the standard will ...

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Technical Writing Tip of the Month – February 2019

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: The document must convey the most important message and direct the reader to any relevant detail. Remember, the most important mes...

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