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
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 of maintaining the safety, integrity, quality, and effectiveness of medical devices. […]