GAP Analysis vs. Internal Audit: Selecting the Best Approach
Nadia Ragnvald Caspersen Senior consultant, Medical Device QA – GBA Key2Compliance In the high-stakes world of medical devices, where patient safety and regulatory compliance are non-negotiable, understanding the nuances between GAP analysis and internal audits can be a game-changer. While both are valuable tools for enhancing performance and ensuring regulatory adherence, they serve distinct purposes […]
Is your Medical Device Software ready for MDR?
The clock is ticking for MDR. The Medical Device Regulation (MDR) is fully applicable since May 26th 2021, and no later than May 26th 2024, all medical device software must be compliant with MDR. To make your medical device software MDR compliant, we recommend you to: Update or create your QMS Update or create your […]