The medical devices regulations (MDRs) were introduced to take account of scientific and technological advances over the past two decades, but also due to problems interpreting previously existing regulations.
Comparison software offers immense savings, especially in regulated industries. Ask some of the leading pharmaceutical companies. Here are 6 Ways You Save.
Risks, stress and more – there’s a lot at stake when you proofread in regulated industries. Here are nine reasons why proofreading in life sciences can be a nightmare.
First, by proofreading, we mean text comparison of 2 files, like a manuscript versus a laid-out artwork of what should be the same text, not content correction of a single text. Over the years, many proofreaders have shared with us what manual text comparison really means for them. When they try to convince their boss to invest in electronic text comparison software, they usually present the business reasons, discussing ROI, risk avoidance, improved quality, time savings and so on.
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Unicode is a computer and software industry standard for handling text. While it is possible to geek-out on the technical aspects of Unicode (and if you’re so inclined you can check out the Wikipedia page on Unicode and the Unicode Consortium website), in this article we’re going to focus more on understanding the fundamentals, and discuss why this basic knowledge is critical for anyone who is part of a document creation / editing / review / correction workflow in a highly regulated industry.
In a previous post, we covered the basics of Unicode and why it’s so important for proofreaders (or anyone involved in the document creation, review and correction workflow) to understand the differences between the way humans and computers read language. Today, we’ll build on that knowledge as we examine different ways design and print proofs can be exported to PDF and the risks associated with removing live text from your organization’s documents.
Explore the impact of labeling errors on pharmaceutical recalls. Find out how to avoid these mistakes and maintain compliance with industry regulations.
The EU Medical Device Regulations (MDR) states any device manufacturer with a website must publish user information in electronic form.
Over the last few posts, we have been touching upon different labelling requirements set by the MDR.
