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Read our Blog

Top ten CAPA errors
13April

What are the top ten CAPA deficiencies?

By John Lafferty, Life Sciences Programme Director at SQT Training...

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13September

FDA’s New Draft Guidance – A New Dawn for Software Validation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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Audit Non-conformities image
21June

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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17December

Publication of Z Annexes and the Harmonisation of ISO 14971:2019

This is our latest article on the Harmonisation of EN...

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6 Reasons why Benefit-Risk Analysis is required for Individual Risks under the MDR/IVDR

Written by John Lafferty Read time: 3 minutes In response...

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Technical Writing Tip – Visual Analogies – How and When to Use Them

Written by John Lafferty Read time: 2 minutes For those...

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Technical Writing Tip – Writing Style

Written by John LaffertyRead time: 2 minutes Writing Style Tailor...

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Technical Writing Skills Tip – The Description

Written by John Lafferty Read time: 2 minutes The Description...

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Technical Writing Tip – The Outside-In Approach to Technical Writing

Written by John Lafferty Read time: 2 minutes Don’t write...

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Technical Writing Tip – Understand your Audience

Written by John Lafferty Read time: 2 minutes Understanding your...

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Technical Writing Tip – Key Elements of a Good Technical Document

Written by John Lafferty Read Time: 2 minutes A good...

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Technical Writing Tip – Using Paragraphs

Written by John Lafferty Read time: 2 minutes A good...

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Is Analysis of Multiple-Fault Conditions a Requirement of ISO14971?

Written by: John Lafferty. Read time: 5 minutes The above...

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23February

What’s the difference between EN and ISO versions of 14971:2019? Part 2

Written by John Lafferty (Read Time: 3 minutes) Following on...

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Is there a difference between EN and ISO versions of 14971:2019? Part 1

EN ISO 14971:2019 Medical devices – Application of risk management...

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How to Win a Rugby World Cup Using Lean Six Sigma

Read Time: 5 minutes Written by: John Lafferty. 1. Keep...

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ISO 14971 Content Deviation #6 and #7

During the process of harmonisation of ISO 14971: 2007 as...

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ISO 14971 Content Deviation #5: Risk Control Options

Read Time: 5 minutes Written by: John Lafferty. During the...

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ISO 14971 Content Deviation #4 Risk/Benefit Analysis

Read Time: 5 minutes Written by: John Lafferty. During the...

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ISO 14971 Content Deviation #3: The Economic Considerations of Risk Reduction

Read Time: 5 minutes Written by: John Lafferty.  During the process...

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ISO 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...

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Are you EN 14971: 2012 compliant? Understanding Content Deviations

Written by John Lafferty. Read Time: 4 minutes. Part 1...

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What are the Software Validation Requirements of ISO 13485:2016?

What are the Software Validation Requirements of ISO 13485:2016? In...

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Why is everyone talking about MDSAP and Health Canada?

Read Time: 5 minutes Written by: John Lafferty. This blog is...

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MDSAP Blog Part 2 – The Audit Process

Read Time: 5 minutes Written by: John Lafferty. As we have seen...

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Linden

Drumardagh

Letterkenny
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Ireland

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