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What are the top ten CAPA deficiencies?
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FDA’s New Draft Guidance – A New Dawn for Software Validation
by John Lafferty Read time: 3 minutes The FDA has...
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Seven Steps to Take if you Receive Significant Medical Device Audit Non-conformities
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Read MoreIs Analysis of Multiple-Fault Conditions a Requirement of ISO14971?
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What’s the difference between EN and ISO versions of 14971:2019? Part 2
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Read MoreHow to Win a Rugby World Cup Using Lean Six Sigma
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During the process of harmonisation of ISO 14971: 2007 as...
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Read MoreISO 14971 Content Deviation #4 Risk/Benefit Analysis
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Read MoreISO 14971 Content Deviation #3: The Economic Considerations of Risk Reduction
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Read MoreISO 14971: 2012 Compliance Content Deviations #1 and #2: Treatment of Negligible Risks and Risk Acceptability
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Read MoreAre you EN 14971: 2012 compliant? Understanding Content Deviations
Written by John Lafferty. Read Time: 4 minutes. Part 1...
Read MoreWhat are the Software Validation Requirements of ISO 13485:2016?
What are the Software Validation Requirements of ISO 13485:2016? In...
Read MoreWhy is everyone talking about MDSAP and Health Canada?
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