Maria Nyåkern, Ph.D.
Maria Nyakern is an accomplished leader and entrepreneur with two decades of expertise in the healthcare and MedTech industries. She has successfully established and expanded several consulting firms focused on medical device innovation and clinical research. As the founder of AKRN Scientific Consulting, a leading Madrid-based medical device CRO, Maria spearheaded significant business growth, culminating in the strategic acquisition of AKRN by the North American CRO, NAMSA, in 2022. This acquisition significantly enhanced clinical development and commercial capabilities in the medical devices sector.
Maria is celebrated for her extensive expertise in the clinical evaluation and investigation of medical devices, particularly those integrated with AI, adhering to stringent EU MDR 2017/745 and ISO 14155:2020 standards. Her dedication to advancing medical technology and fostering emerging scientific talent has been recognized on a European level, underscoring her contributions to scientific progress, technology transfer, and societal improvement across Europe.