By John Lafferty, Life Sciences Programme Director at SQT Training...
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FDA’s New Draft Guidance – A New Dawn for Software Validation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
If you have received significant non-conformities from a regulatory body...
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Publication of Z Annexes and the Harmonisation of ISO 14971:2019
This is our latest article on the Harmonisation of EN...
Read More6 Reasons why Benefit-Risk Analysis is required for Individual Risks under the MDR/IVDR
Written by John Lafferty Read time: 3 minutes In response...
Read MoreTechnical Writing Tip – Visual Analogies – How and When to Use Them
Written by John Lafferty Read time: 2 minutes For those...
Read MoreTechnical Writing Tip – Writing Style
Written by John LaffertyRead time: 2 minutes Writing Style Tailor...
Read MoreTechnical Writing Skills Tip – The Description
Written by John Lafferty Read time: 2 minutes The Description...
Read MoreTechnical Writing Tip – The Outside-In Approach to Technical Writing
Written by John Lafferty Read time: 2 minutes Don’t write...
Read MoreTechnical Writing Tip – Understand your Audience
Written by John Lafferty Read time: 2 minutes Understanding your...
Read MoreTechnical Writing Tip – Key Elements of a Good Technical Document
Written by John Lafferty Read Time: 2 minutes A good...
Read MoreTechnical Writing Tip – Using Paragraphs
Written by John Lafferty Read time: 2 minutes A good...
Read MoreIs Analysis of Multiple-Fault Conditions a Requirement of ISO14971?
Written by: John Lafferty. Read time: 5 minutes The above...
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What’s the difference between EN and ISO versions of 14971:2019? Part 2
Written by John Lafferty (Read Time: 3 minutes) Following on...
Read MoreIs there a difference between EN and ISO versions of 14971:2019? Part 1
EN ISO 14971:2019 Medical devices – Application of risk management...
Read MoreHow to Win a Rugby World Cup Using Lean Six Sigma
Read Time: 5 minutes Written by: John Lafferty. 1. Keep...
Read MoreISO 14971 Content Deviation #6 and #7
During the process of harmonisation of ISO 14971: 2007 as...
Read MoreISO 14971 Content Deviation #5: Risk Control Options
Read Time: 5 minutes Written by: John Lafferty. During the...
Read MoreISO 14971 Content Deviation #4 Risk/Benefit Analysis
Read Time: 5 minutes Written by: John Lafferty. During the...
Read MoreISO 14971 Content Deviation #3: The Economic Considerations of Risk Reduction
Read Time: 5 minutes Written by: John Lafferty. During the process...
Read MoreISO 14971: 2012 Compliance Content Deviations #1 and #2: Treatment of Negligible Risks and Risk Acceptability
Read Time: 5 minutes Written by: John Lafferty. In a previous...
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?
Read Time: 5 minutes Written by: John Lafferty. This blog is...
Read MoreMDSAP Blog Part 2 – The Audit Process
Read Time: 5 minutes Written by: John Lafferty. As we have seen...
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