Publication of Z Annexes and the Harmonisation of ISO 14971:2019
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…
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 to my post on "What is the Difference between the EN and ISO versions of 14971:2019 Part 2?" I received…
Technical Writing Tip – Visual Analogies – How and When to Use Them
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…
Technical Writing Tip – Writing Style
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…
Technical Writing Skills Tip – The Description
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.…
Technical Writing Tip – The Outside-In Approach to Technical Writing
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…
Technical Writing Tip – Understand your Audience
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…
Technical Writing Tip – Key Elements of a Good Technical Document
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…
Technical Writing Tip – Using Paragraphs
Written by John Lafferty Read time: 2 minutes A good document should have a clear structure. Dividing your document into multiple paragraphs will result in a document which is much…
Is Analysis of Multiple-Fault Conditions a Requirement of ISO14971?
Written by: John Lafferty. Read time: 5 minutes The above question was posed by one of the delegates at one of my recent Quality Risk Management and ISO 14971:2019 training…