Timing is Everything: The Crucial Role of QMS in Your Medical Device Journey
Nadia Ragnvald Caspersen Senior consultant, Medical Device QA/RA- GBA Key2Compliance For startups in the medical device sector, the timing of your Quality Management System (QMS) implementation can significantly influence your path to market and the submission of your technical file. While it may be tempting to focus solely on product development, integrating a QMS early […]
Quality Culture -Technology helps, but people make it work
Nadia Ragnvald Caspersen Senior consultant, Medical Device QA/RA – GBA Key2Compliance Picture this: You’re racing to meet a production deadline, juggling compliance requirements, and fighting to keep costs under control. Amid all that pressure, one question looms large: How do we make quality more than a tick-box exercise? Because quality isn’t just a requirement. It’s the backbone of trust, the measure of […]
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 […]
Can You Measure Your Quality?
Dr. Peter L. Knepell President of Peak Quality Services If you want to buy an electronic thermometer, a blood pressure cuff, a pulse-oximeter, or a blood glucose meter, you probably do not give much thought about its accuracy or precision. Should you? More importantly, how about manufacturing these or other medical devices that depend on […]