Inside the Role of a Clinical Project Manager – Meet Anna Östblom
Clinical investigations are complex by nature. With tight timelines, limited budgets, and regulatory expectations, they demand coordination at every level. That’s where experienced project managers like Anna Östblom come in. “What might surprise people is how much time it actually takes to manage a study,” says Anna. “My work is less visible compared to for example the […]
Webinar: Why Most Device Start-up Companies Struggle to Survive – Ways to Thrive and Prosper!
In the MedTech industry, 8 out of 10 start-up companies don’t make it past their first 7 years. Why do so many fail, and how can you avoid the most common pitfalls? Join experienced speakers from GBA Key2Compliance and BAAT Medical for a deep dive into the challenges start-ups face and discover strategies to thrive. […]
How ISO13485 prepares your IVDR Quality System for audits and what it doesn’t cover
Register today! May 27, 2025 10:30 – 11:15 CET Join our Free Webinar on IVDR Compliance for In Vitro Diagnostic Medical Device Manufacturers With the upcoming IVDR compliance deadline at the end of May, it’s crucial to ensure your organization is fully prepared. This webinar will provide a comprehensive overview of the most critical aspects […]
How Strategic Knowledge Management Can Future-Proof Your GxP Organization
Afifa Trad and Evelina Philipson, Pharma QA Consulting and Training, GBA Key2Compliance In highly regulated GxP environments, knowledge is power. Strategic knowledge management is a critical foundation for life science organizations aiming to remain audit-ready, drive continuous improvement, and reduce operational risk. At GBA Key2Compliance, we believe that real change starts when the right people have […]
Medical Device Classification Under MDR & IVDR: What Manufacturers Need to Know
Why Medical Device Classification Matters If you’re a medical device or in vitro diagnostic (IVD) manufacturer, one of the first regulatory hurdles you’ll face is classification. This might sound like a technicality, but getting it right is crucial—it determines how much regulatory oversight your product needs, how long it will take to get to market, […]
Why Less is More in Clinical Data – Insights from Senior Clinical Data Manager Åsa Testad
Åsa Testad’s career began with a background in informatics and programming—skills that today serve as the foundation of her work in clinical studies. After entering the field in the late 1990s, Åsa transitioned into data management and found a role that combined problem-solving, structure, and collaboration. “My role involves working at the intersection of different […]
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 […]