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Month: February 2025

Simplifying IVDR Compliance: Insights from Senior Consultant Emily Malmberg

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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

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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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