Navigating IVDR Certification: Prostatype’s Success Story with GBA Key2Compliance
Prostatype Genomics is at the forefront of precision medicine, offering the Prostatype® test—a groundbreaking genetic diagnostic tool designed to assess the aggressiveness of prostate cancer. By providing crucial insights, Prostatype helps clinicians and patients make informed treatment decisions, ultimately improving patient care and optimizing healthcare resources. Prostatype has an ability to significantly improve the quality […]
Simplifying IVDR Compliance: Insights from Senior Consultant Emily Malmberg
Emily Malmberg’s passion for medicine and biology led her from academia into the dynamic field of medical devices. As a Senior Consultant at GBA Key2Compliance, she leverages her extensive background to guide companies through the intricacies of the In Vitro Diagnostic Regulation (IVDR). “Transitioning from academia to the medical device industry allowed me to apply […]
Join Our Free BioComp Bootcamp Webinar Series!
Are you working with biocompatibility or clinical evaluation in the medical device industry? Our BioComp Bootcamp webinar series is designed to help you stay informed and up to speed—quickly and efficiently. Each 20-minute session dives into a key topic, providing valuable insights, expert guidance, and practical resources to support your work. Why Join? Short & […]
Meet Us at Regulatory Summit 2025!
GBA Key2Compliance is looking forward to participating in this year’s Regulatory Summit, organized by Swedish Medtech. Now in its 8th edition, this event is one of the most important meeting places of the year for industry experts and leaders to discuss and analyze the challenges and changes related to MDR. As a Networking Partner to […]
Setting Strategic Direction for Medical Devices: The Role of Quality Management
Nadia Ragnvald Caspersen Senior consultant, Medical Device QA – GBA Key2Compliance For companies seeking success in the highly regulated medical device market, setting a strategic direction that emphasizes quality management is a non-negotiable requirement. A well-planned quality management strategy can streamline regulatory compliance, foster innovation, and enhance operational efficiency. Companies that prioritize quality as a […]
Ownership and Accountability in Medical Device Quality Management
Nadia Ragnvald Caspersen Senior consultant, Medical Device QA – GBA Key2Compliance Accountability and ownership are critical for maintaining high standards of quality in any organization. In the medical device sector, where patient safety is paramount, these elements become even more vital. Effective quality management depends on leaders, teams, and individuals who understand their roles and […]
Embedding Quality Management in Medical Device Business Decisions
Nadia Ragnvald Caspersen Senior consultant, Medical Device QA – GBA Key2Compliance When it comes to ensuring the safety, effectiveness, and regulatory compliance of medical devices, quality management cannot be left as an afterthought. Business decisions, from the early stages of development to the final stages of manufacturing, must be driven by a commitment to quality. […]
The Crucial Role of Management in Quality for the Medical Device Industry
Nadia Ragnvald CaspersenSenior consultant, Medical Device QA – GBA Key2Compliance In the highly regulated medical device industry, quality is not just a checkbox—it is a cornerstone of successful business operations. The importance of quality management in this field cannot be overstated, as it plays a vital role in ensuring product safety, regulatory compliance, and long-term […]
5 most common misconceptions about biocompatibility
Kristina FantDirector, Biological Safety – GBA Key2Compliance For any device that comes in contact with either a patient or a user, it is crucial to assess possible biological risks early in the development process. However, there are a lot of misunderstandings that we commonly encounter in our daily work with different medical device manufacturers. See […]
Safe Integration of Electrical Safety and Software in Medical Devices
Gustav SundströmSenior Consultant, Regulatory Affairs – GBA Key2Compliance The medical device industry holds patient safety as a top priority, but as devices grow increasingly complex, ensuring their safety demands more than just careful design—it requires a comprehensive approach. Today, medical devices rely heavily on both electrical safety mechanisms and medical device software (MDSW) to function […]