Hanna Gradin

Throughout her career, Hanna has held senior leadership and specialist roles, leading quality and regulatory functions, developing high-performing teams and driving both operational and strategic improvements. Experience includes QMS design and transformation, MDR/IVDR transitions, inspection readiness, risk management, audits and organizational change initiatives.

Hanna is particularly driven by helping companies view regulatory and quality requirements as strategic enablers rather than constraints. By combining a structured, pragmatic and hands-on approach with a strong strategic perspective, Hanna support clients in integrating compliance into product lifecycles and business processes – enabling innovation, patient safety and sustainable growth.