Is Your Innovation a Medical Device?
Demystifying Regulatory Pathways for Entrepreneurs Zahra MavajianRegulatory 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 if […]
Developing Medical Device Software: Essential Insights for Founders
Claudia DannehlSenior 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 aim […]
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 […]
Why Medical Device is basically Rocket Science
Nadia Ragnvald CaspersenSenior 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 one of […]
Our QA/RA consultants shine – both as experts and photographers!
Recently, our QA/RA team gathered for an inspiring workshop where we not only deepened our expertise but also explored our creative side. We participated in an engaging activity led by Catarina Harling, Photographer and Teacher from the Fotografiska Museum. She taught us how to effectively use our iPhones for photography, with a particular focus on […]
Quality and Compliance for ATMPs – A Strategic Enabler for Patient Access
Afifa TradSenior consultant, Pharma QA – GBA Key2Compliance Advanced Therapy Medicinal Products (ATMPs) are transforming the treatment landscape for complex and previously untreatable diseases. By leveraging gene therapy, cell-based treatments, and tissue engineering, these therapies offer truly personalized solutions. But with innovation comes complexity—and success depends on one key factor: a robust strategy for quality […]
What It Takes to Keep a Clinical Study Going
– Meet Clinical Research Associates Ana Zamani and Susanna Hellström Clinical studies aren’t just about data collection. It’s about keeping studies on track through operational teamwork and navigating challenges in real time. For Ana Zamani and Susanna Hellström, Clinical Research Associates (CRAs, also called Monitors) at GBA Key2Compliance, this human side of clinical studies is […]
Camilla Oldgren Appointed New CEO of GBA Key2Compliance
GBA Key2Compliance AB is pleased to announce the appointment of Camilla Oldgren as its new Chief Executive Officer (CEO), effective June 1, 2025. Camilla brings over 30 years of experience in the life sciences industry, with deep expertise in pharmaceuticals, medical devices, and consulting services. Her professional journey spans executive leadership in established companies as […]
IVDR Compliance Deadline – Are You Prepared?
The IVDR compliance deadline is here! If you’re a manufacturer, it’s crucial to ensure your Quality Management System (QMS) is compliant and your IVDR application is submitted to a Notified Body. For Class D IVD manufacturers, this includes submitting the application and getting a written agreement with a Notified Body by September 26, 2025. Ensuring […]