Quality Risk Management, Powered by People
Nadia Ragnvald Caspersen Senior consultant, Medical Device QA/RA – GBA Key2Compliance Building better systems through respect, teamwork, and ongoing improvement Quality management isn’t just about systems and standards—it’s about people. Every device we help bring to market is ultimately used by someone who trusts it with their wellbeing. As QA/RA professionals, our responsibility goes far beyond compliance; it’s about safeguarding lives, supporting clinicians, and earning […]
Meet Malin Truvé, one of our Usability Evaluation experts!
Usability evaluations for better safety and design of medical devices Usability evaluations are connected to the risk management and is an important part of the technical documentation. Performing formative and summative evaluations will make sure that the user of the medical device can use it safely. Usability evaluations are not only important for the sake […]
Improve your risk management procedures
ISO 14971:2019, the internationally harmonized standard, stating how to reduce risks, increase patient safety and ensure that you as a manufacturer can bring your medical devices to the market safely and efficiently. Our new course will give you a thorough understanding of ISO 14971:2019 and how adopting the internationally harmonized standard early in the process […]