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Author: admin

This author has written 25 articles
Read more about the article FDA’s New Draft Guidance – A New Dawn for Software Validation

FDA’s New Draft Guidance – A New Dawn for Software Validation

  • Post author:admin
  • Post published:September 13, 2022
  • Post category:Uncategorized
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by John Lafferty Read time: 3 minutes The FDA has just issued its long-awaited draft guidance on Software Validation. The new draft guidance entitled Computer Software Assurance for Production and…

Continue ReadingFDA’s New Draft Guidance – A New Dawn for Software Validation
Read more about the article Seven Steps to Take if you Receive Significant Medical Device Audit Non-conformities

Seven Steps to Take if you Receive Significant Medical Device Audit Non-conformities

  • Post author:admin
  • Post published:June 21, 2022
  • Post category:Uncategorized
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If you have received significant non-conformities from a regulatory body e.g., a Notified Body, the FDA or an MDSAP Auditing Organisation, what should you do? By John Lafferty Read Time:…

Continue ReadingSeven Steps to Take if you Receive Significant Medical Device Audit Non-conformities
Read more about the article Publication of Z Annexes and the Harmonisation of ISO 14971:2019

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

  • Post author:admin
  • Post published:December 17, 2021
  • Post category:Uncategorized
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This is our latest article on the Harmonisation of EN ISO 14971:2019. It has been a long two years since ISO 14971:2019 Medical Devices – Application of Risk Management was…

Continue ReadingPublication of Z Annexes and the Harmonisation of ISO 14971:2019

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

  • Post author:admin
  • Post published:March 26, 2021
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Written by John Lafferty Read time: 3 minutes In response to my post on "What is the Difference between the EN and ISO versions of 14971:2019 Part 2?" I received…

Continue Reading6 Reasons why Benefit-Risk Analysis is required for Individual Risks under the MDR/IVDR

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

  • Post author:admin
  • Post published:February 24, 2021
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Written by John Lafferty Read time: 2 minutes For those of you who have been following our Technical Writing Tips of the Month, you will be familiar with the "Outside-In…

Continue ReadingTechnical Writing Tip – Visual Analogies – How and When to Use Them

Technical Writing Tip – Writing Style

  • Post author:admin
  • Post published:February 24, 2021
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Written by John LaffertyRead time: 2 minutes Writing Style Tailor your writing style for your intended reader to make your document more effective and easier to understand. Always bear in…

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Technical Writing Skills Tip – The Description

  • Post author:admin
  • Post published:February 24, 2021
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Written by John Lafferty Read time: 2 minutes The Description in a Technical Report The majority of technical reports include some type of description, either of objects, processes or ideas.…

Continue ReadingTechnical Writing Skills Tip – The Description

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

  • Post author:admin
  • Post published:February 24, 2021
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Written by John Lafferty Read time: 2 minutes Don’t write about what you know; write about what the reader needs to know. The Outside-In approach is the technique of writing…

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Technical Writing Tip – Understand your Audience

  • Post author:admin
  • Post published:February 24, 2021
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Written by John Lafferty Read time: 2 minutes Understanding your Audience - Stepping into the Reader’s Shoes is the Key to Good Technical Writing • To understand the audience you…

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Technical Writing Tip – Key Elements of a Good Technical Document

  • Post author:admin
  • Post published:February 23, 2021
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Written by John Lafferty Read Time: 2 minutes A good document is one that gives a clear message which all of the intended readers can easily understand. Key elements of…

Continue ReadingTechnical Writing Tip – Key Elements of a Good Technical Document
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Blog

  • FDA’s New Draft Guidance – A New Dawn for Software Validation
    September 13, 2022
    by John […]
  • Audit Non-conformities imageSeven Steps to Take if you Receive Significant Medical Device Audit Non-conformities
    June 21, 2022
    If you have […]
  • Publication of Z Annexes and the Harmonisation of ISO 14971:2019
    December 17, 2021
    This is our […]
  • 6 Reasons why Benefit-Risk Analysis is required for Individual Risks under the MDR/IVDR
    March 26, 2021
    Written by […]
  • Technical Writing Tip – Visual Analogies – How and When to Use Them
    February 24, 2021
    Written by […]
  • Technical Writing Tip – Writing Style
    February 24, 2021
    Written by […]
  • Technical Writing Skills Tip – The Description
    February 24, 2021
    Written by […]
  • Technical Writing Tip – The Outside-In Approach to Technical Writing
    February 24, 2021
    Written by […]
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