Maria Nyåkern, Ph.D

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.

TRAINING & COURSES

NEWS

More about María

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.

CORE COMPETENCIES

  • Solid expertise in endovascular aortic repair (EVAR), interventional cardiology, structural heart disease (TAVR), and minimally invasive treatments. 
  • Expert competence in Clinical Evaluations and Clinical Investigations according to MEDDEV 2.7/1 Rev4, ISO 14155:2020, European Medical Device Regulations (MDR 2017/745).
  • Advising sponsors on strategy for device intended purpose, clinical evaluation, CE mark submissions, clinical investigation designs.
  • Supporting sponsors for the start-up and planning of clinical investigations in Europe (resources, budget, stakeholders, ISO 14155 GCP compliance)
  • Advising on and preparing clinical investigation plans (CIP) according to ISO 14155:2020 for a wide variety of devices.
  • Overseeing the review of over dozens of medical device clinical evaluation reports (CER) and performance evaluation reports (PER)

RECENT PROJECTS

  • Clinical Performance Study for Rapid Antigen Detection test for SARS-CoV-2 
  • Clinical investigation of heart preservation device compared to cold static storage of donor hearts
  • Clinical investigation to assess safety and performance of derma filler
  • Post-Market Clinical Follow-up for vascular device in the determination of presence or absence of PAD
  • Clinical investigation (FIM) to assess safety and performance of device to treat resistant hypertension 
  • Clinical investigation (FIM) to assess safety and performance of device to treat heart failure and reduced ejection fraction
  • Feasibility study to evaluate the initial safety and performance of device for of AIS due to LVO in the intracranial ICA, M1, M2, basilar or vertebral arteries
  • Investigator-initiated clinical investigation for ESAR (EVAR plus Heli-FX EndoAnchors) and FEVAR for the treatment of aortic aneurysms with short infrarenal aortic neck
  • Clinical Evaluation Report (CER) transition to the Medical Device Regulation (MDR) 2017/745 for a class IIa device (aspiration pumps for aspiration of follicular fluid, oocytes and ovarian fluid as part of the treatment for infertility relating to IVF)
  • Clinical Evaluation Report (CER) transition to the Medical Device Regulation (MDR) 2017/745 for a class IIb device (vescioamniotic shunt)
  • Literature Review under the Medical Device Regulation (MDR) 2017/745 for a class IIa/IIb device
  • Clinical and regulatory advising on pre-clinical and clinical development for Invasive surgery assistant robot
  • Clinical Evaluation Report (CER) under the MDR for class IIa Medical Devices (IV solution administration)
  • Clinical Evaluation Report (CER) under the MDR for class III Medical Devices (breast implant/Tissue Expander)
  • Clinical Evaluation Report (CER) under the MDR for class III Medical Devices (chemical peeling)
Privacy Overview

This website uses cookies so that we can provide you with the best user experience possible. Cookie information is stored in your browser and performs functions such as recognising you when you return to our website and helping our team to understand which sections of the website you find most interesting and useful.