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ISO 13485:2016 Companion Handbook Now Available

ISO has published a companion handbook to ISO 13485:2016, Medical..


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A Risk-Based Approach to Your QMS Implementation ...

Part of your month, every month: R&Q Intelligence Series webinars are held on..

QMS, iso 13485

Vital To-Do for 2017: Prepare for ISO 13485:2016

“Procrastination is the bad habit of putting of until the day after tomorrow..

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Minnesota Momentum: R&Q Hires Member of ISO ...

Mark Swanson is R&Q's new Director of Minneapolis–Saint Paul (MSP) Territory...

iso 13485

10 Tips for Adopting the Updated ISO 13485:2016 ...

Missed our latest webinar on this year's ISO 13485 changes? Now you can..

iso 13485

The New ISO 13485 Standards are Here! Sign Up for ...

The world's most well known standards for medical device quality management..

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FDA’s Guidance Document on Voluntary Submission ...

I came across an FDA guidance document – not entirely recent; however, I found..

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A QMS Outcast: Preventive Action

We in the medical device industry throw the term CAPA around like it's a word..

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Making Sense of Standards

You may have heard that last year there were two new releases of EN standards:..

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Architect of Quality - Part 1

Have you ever wondered where quality management systems came from, or why these..