Why Less is More in Clinical Data – Insights from Senior Clinical Data Manager Åsa Testad

Effective data management isn’t about collecting everything—it’s about planning what truly matters and ensuring it’s collected in a way that supports compliance and analysis. – Åsa Testad, Senior Clinical Data Manager

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

Picture of 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

Two regulatory specialists discussing a case in front of acomputer screen.

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 […]

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