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 […]
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 Trad Senior 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 […]
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 […]
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 […]