MDR Is Not Too Complex – The Importance of a Clear Clinical Strategy
Jeanette Demorney Senior Advisor, Clinical Development – GBA Key2Compliance One of the most common statements you hear in MedTech right now is that MDR is simply too complex. It is often described as bureaucratic, unpredictable, and overly demanding, particularly for small and mid-sized companies. For many, the regulation itself has become the explanation for why […]
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 […]
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 […]
Outsourcing Internal Audits in MedTech: Strategic Advantage or Regulatory Risk?
Nadia Ragnvald Caspersen Senior consultant, Medical Device QA – GBA Key2Compliance In the medical device industry, internal audits are a vital part of maintaining compliance, ensuring product safety, and preparing for regulatory inspections. But as companies face increasing complexity, limited resources, and the pressure of unannounced audits, many are asking: Is it acceptable to outsource […]
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 […]
Why Medical Device is basically Rocket Science
Nadia Ragnvald Caspersen Senior consultant, QA/RA – GBA Key2Compliance “We choose to go to the moon… not because it is easy, but because it is hard.” (John F. Kennedy) – Honestly, he could’ve been talking about bringing a medical device to market. It’s hard. It’s expensive. It’s regulated to the moon and back. But it’s also […]