Risk-based thinking is one of those phrases that is mentioned frequently within ISO management system…
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By IJ Arora, Ph.D. ISO 13485:2016 is a standard that addresses quality management system…
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Ralph Hiltebrand is the principal and co-founder of GHR Associates. He has more than 20…
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by Sandrine Tranchard The medical devices industry is one of the most highly regulated sectors in…
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TÜV SÜD will host a workshop in March to help manufacturers understand the changing medical…
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ANAB has been approved as a member of the InterAmerican Accreditation Cooperation (IAAC) multilateral recognition…
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by William I. White In structuring quality management systems, most medical device companies choose a…
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