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EU MDR 2017/745: What Importers & Distributors Need to Know (but Often Don’t)

Understanding your responsibilities under MDR and why so many organisations are only discovering them now. Author: Anne Marie Newell Over the last few years, the EU Medical Device Regulation (EU MDR 2017/745) has reshaped the responsibilities of companies handling medical device...

FDA’s Draft Guidance – A New Dawn for Software Validation

By John Lafferty Article updated: March 2025 Read time: 3 minutes The draft guidance entitled Computer Software Assurance for Production and Quality System Software (dated 13th September 2022) represents a new dawn for software validation in a manufacturing environment. New: Un-...

How to Make Software Validation Easier for Compliance with ISO 13485 and Pharma Regulations

By John Lafferty Software Validation just got a whole lot easier. The effort required comply with the software validation requirements of ISO 13485:2016 and 21 CFR Part 820 has been greatly reduced due to recent changes in regulations and guidance. Under the latest guidance, so...

Writing Deviation Reports – Five Common Errors

By John Lafferty, Life Sciences Programme Director Read time: 2 minutes Based on his many years assisting Medical Device and Pharmaceutical companies with their Quality Management Systems, John identifies the following top five deviation report errors and their solutions. No cl...

Writing Deviation Reports – Product Impact Statement

By John Lafferty, Life Sciences Programme Director Read time: 2 minutes When writing a deviation report, it is important to clearly outline the potential impact on product. Lack of clarity on product impact may delay approval of your deviation report or, worse still, it may dela...

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