A warm welcome to our new employees

Say hello to our newest colleagues: Anna Östblom, Bernadette Lechner, Ida Björklund and Linda Rosén! They are joining us to help continue doing what we love to do: make complex things easier – all the way from idea to market. Anna Östblom, Clinical Consultant What will be your role at GBA Key2Compliance? I will join […]
The Important Role of a PRRC in Medical Device and Software Compliance

Åsa Möllby Director, Medical Device Quality Assurance – GBA Key2Compliance One of the changes introduced by the Medical Device Regulation (MDR) in 2017 and the In Vitro Diagnostic Device Regulation (IVDR), is the requirement of a designated Person Responsible for Regulatory Compliance (PRRC). A PRRC bears the important role mandated by the MDR and IVDR […]