How to Create a Risk Management Plan – Medical Devices
by John Lafferty, SQT Life Sciences Programme Director Read time: 4 minutes Risk management standard ISO 14971:2019 has specific requirements for a Risk Management Plan, in order to comply with…
What are the top ten CAPA deficiencies?
By John Lafferty, Life Sciences Programme Director at SQT Training Read time: 2 minutes I have compiled a list of the top ten CAPA deficiencies based on many years of…
FDA’s New Draft Guidance – A New Dawn for Software Validation
by John Lafferty Read time: 3 minutes The FDA has just issued its long-awaited draft guidance on Software Validation. The new draft guidance entitled Computer Software Assurance for Production and…
Seven Steps to Take if you Receive Significant Medical Device Audit Non-conformities
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:…
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…