
Clinical Investigation of Software as Medical Devices (SaMD) – A Focus on AI-Powered Solutions
Course Description: In the rapidly evolving landscape of digital health, software has taken center stage
About Me
I began my professional journey in the world of clinical research, grounded in a doctorate in cell biology and a deep respect for scientific inquiry. Over two decades, I built expertise in medical device innovation, regulatory strategy, and clinical excellence — not as a consultant, but as a founder, mentor, and builder of systems that hold.
In 2022, the company I founded, AKRN Scientific Consulting, was acquired by NAMSA, one of the largest global Contract Research Organizations. But the real story is not the acquisition. It is the quiet discipline, the years of leading high-performing teams, and the ability to translate complex science into meaningful progress. That is what shaped me.
Today, I work across several frontiers:
As an entrepreneur, I support mission-driven ventures and serve as an advisor and investor in early-stage MedTech and AI startups.
As a speaker and trainer, I translate regulatory knowledge, ethical insight, and future-facing strategy into tools for transformation.
As a writer and thinker, I explore the deeper patterns shaping our systems, in governance, technology, medicine, and meaning.
In an era captivated by artificial intelligence, I am drawn to a deeper question: what is intelligence? Not just as computation or prediction, but as coherence with the ability to hold complexity, to act ethically within systems, and to remain attuned to meaning.
I believe we are being called to define a new kind of intelligence. One that is not only systemic but spiritual, not only scientific but symbolic. This intelligence cannot be outsourced to machines. It must be cultivated — in ourselves, in our institutions, and in the ways we relate to the world.
My work now is to integrate these dimensions and to bridge science and soul, regulation and relation — and to support others who are doing the same.
To connect with me.

Course Description: In the rapidly evolving landscape of digital health, software has taken center stage

Welcome to an enriching online course meticulously crafted to guide you through the intricacies of

Navigating Compliance and Technical Documentation Welcome to “Navigating Compliance and Technical Documentation,” a detailed and

Navigating CE Marking for Medical Devices: A Comprehensive Guide The journey to obtaining a CE

Upholding Ethical Excellence in Clinical Trials: Good Clinical Practice (GCP) and ISO 14155 Good Clinical

Introduction In the fast-paced and ever-evolving field of medical device development, conducting clinical studies is
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Dr. Nyåkern has a solid track record of successfully collaborating with the relevant stakeholders, authorities, clinicians and medical device executives, worldwide. In 2017, Maria Nyåkern established ÅKRN Scientific Consulting, a European CRO offering clinical and regulatory services to the medical device and diagnostic industries. In 2022, AKRN and its 40+ employees was acquired by NAMSA.
Maria’s core competencies include CRO business operations, clinical strategic/ optimization planning, clinical evaluation, medical technology business development, Subject Matter Expertise (SME) on EU MDR 2017/745, ISO 14155:2020, and CE-mark strategy. She is a member of the ISO technical committee for biological and clinical evaluation of medical devices (SIS/TK 340 and ISO/TC 194) responsible for developing the ISO 14155 standard regulation clinical investigations of medical devices in human subjects. Maria is a renowned speaker and trainer on the topic of clinical evaluation and clinical investigation of medical devices.
Maria Nyåkern has a strong academic background and international scientific training in Sweden, France, Italy, the United States. Maria Nyåkern is a Doctor of Cell Biology at Stockholm University, Sweden (2003), and has completed a Postdoctoral Fellowship at the University of Bologna, Italy (2006). She is the author of several peer-reviewed papers in the cardiovascular area and she is fluent in English, Spanish, Italian, French, and Swedish.