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 […]
Clinical Evaluation in MedTech – Expert Insights from Sandra Sernbo for Building Safe Medical Devices
At GBA Key2Compliance, the Clinical Research Organization (CRO) team is not only responsible for navigating regulatory requirements but also for ensuring that medical devices make their way into the hands of patients safely and effectively. In a field where innovation is critical but patient safety is non-negotiable, clinical evaluations play a vital role. At the […]
Internal Audits – A Strategic Tool for Continuous Improvement
At GBA Key2Compliance, internal audits are more than a regulatory requirement. They are a proactive way to identify gaps, strengthen your quality system, and ensure you stay ahead of Notified Bodies and Competent Authorities. Our auditors bring deep regulatory knowledge and extensive hands-on industry experience. With expertise across MDR, IVDR, ISO 13485, and MDSAP, we […]
Internal audits – an opportunity to improve Medical Devices
Internal audits are an important activity for medical device manufacturers. It is not only a requirement for ISO 13485 compliance, but also an opportunity to get valuable feedback that can help to improve both the medical device and the development process. At GBA Key2Compliance, our experienced auditors support clients throughout the entire internal audit process – ensuring compliance, […]
Is Your Innovation a Medical Device?
Demystifying Regulatory Pathways for Entrepreneurs Zahra Mavajian Regulatory affairs and Quality assurance consultant – GBA Key2Compliance Are you an entrepreneur with great ideas to impact your field, whether through a new device, software, service, or system? If so, you might be wondering: Does my innovation fall under Medical Device Regulation? And more importantly, what happens […]
Developing Medical Device Software: Essential Insights for Founders
Claudia Dannehl Senior consultant, Medical Device RA – GBA Key2Compliance Many software development companies fear the classification of their software as a medical device, because developing a medical device means following many regulations. However, there are also few advantages to having software applications that qualify as medical device software (MDSW). In this blog post, we […]
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 […]
Safety Data That Makes a Difference – Insights from Safety Manager Ida Björklund
In clinical studies, the responsibility for ensuring patient safety lies with both the sponsors and the clinical study staff. This is not only a regulatory requirement, outlined in standards such as the MDR (Medical Device Regulation) and IVDR (In Vitro Diagnostic Regulation), but also a core principle of Good Clinical Practice (GCP) and its ISO […]