by John Lafferty Read time: 3 minutes The FDA has just issued its long-awaited draft guidance on Software Validation. The new draft guidance entitled Computer Software Assurance for Production and…
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:…
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…
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…
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…
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…
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.…
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…
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…
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…