Karin Ackema

Strategic MedTech expert with solid cross-functional experience along a wide product range. Agile and pragmatic leader, supporting innovation with excellent problem-solving skills and engagement of multidisciplinary teams. Established scientific background and a scientific mindset. Having worked with start-ups in different stages, I bring value by focusing on pragmatic and agile solutions that allow for scaling and pivoting. As part of this, I ensure that regulatory planning is strategically positioned not only to meet regulatory expectations but also to demonstrate to board members and investors that the company uses its capital effectively.

Led quality, regulatory and clinical strategy for MedTech and Digital Health Industry for innovative products.

Regulatory/scientific due diligence, QMS implementation strategies, portfolio analysis, risk mitigation strategies.

Speaker, university lecturer, trainer, medical and scientific writer, peer-reviewed publications.