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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
The New Required Role of Person Responsible for Regulatory Compliance
The new medical device regulations MDR and IVDR have introduced a new role: Person Responsible for Regulatory Compliance (PRRC). According to Article 15 of MDR and IVDR, manufacturers of medical devices are now required to have a designated person who will be responsible for regulatory compliance (PRRC), ensuring that all post-market surveillance and obligations are […]