Whether you are being audited by a Notified Body or one of the Regulators, you are being audited by someone external to your organisation. This comes with great opportunities as...

In this article we focus on how to prepare the audit backroom for a smooth audit. You may have been hosting your audits without much preparation or strategy, and things have...

This is a checklist of tasks to do or check prior and during the opening meeting, as well as items to go through during the closing meeting to ensure a...

How to properly use Quality Sampling for Process Validation? When it comes to sampling of medical devices, we have seen numerous times that the production manager or quality engineer truly wants...