A warm welcome to our new employees
Say hello to our newest colleagues: Evelina Greschner, Ana Zamani and Susanne Glantz! They are joining us to help continue doing what we love to do: make complex things easier – all the way from idea to market. Evelina Greschner, Marketing Operations Assistant What will be your role at Key2Compliance? At Key2Compliance, my role will […]
Join GBA Key2Compliance at GoCo’s Open House Event!
We’re thrilled to invite you to join us at GoCo Health Innovation City’s Open House event on May 13. For the second year in a row, the companies at GoCo are opening their doors to showcase the dynamic ecosystem we’re building together. You’re invited to take part – free of charge. Join us for a […]
Strengthening MDR Compliance Through Literature Search
Johanna Fugelstad and Anna Sahlholm, Clinical Development, GBA Key2Compliance It is not uncommon that manufacturers think of the required structured literature search as yet another checkbox and that it is performed very late in the process of finalizing the technical documentation. Or it is performed once and never updated. Thinking ahead, the literature search can […]
GBA Key2Compliance at RAPS Euro Convergence 2025 in Brussels!
GBA Key2Compliance is excited to attend RAPS Euro Convergence 2025 in Brussels! Join us from May 13-16 for Europe’s most comprehensive regulatory affairs conference, focusing on the latest developments and topics in healthcare products across Europe and beyond. Visit us at Booth #5 Our team – Helena Dahlin, Director Quality Assurance & Regulatory Affairs, and […]
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 […]