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Maria Nyåkern, Ph.D

A Journey Defined by Commitment

My career began in clinical research, driven by a passion for medical device technology. My foundation includes a doctorate in cell biology and a strong background in academic research.

I focused deeply on scientific innovation, developing extensive expertise and a strong commitment to improving the development of medical devices. This dedication led to the success of my medical device consulting firm, AKRN Scientific Consulting, which was acquired by NAMSA, a major North American Contract Research Organization (CRO), in 2022.

Now, I use my broad experience in roles such as speaker and trainer, and enjoy mentoring startups. I provide them with practical advice to succeed in the competitive medical device industry.

I also participate in industry events, highlighting new trends in medical devices, with a focus on clinical research and the growing importance of artificial intelligence. In addition to MedTech, I combine science with storytelling in the Media Industry, using this blend to explain complex ideas in an innovative way and encourage change.

With my experience and dedication, I am ready to provide guidance and support. Whether you’re looking to expand your industry knowledge or seeking specialized advice for your medical device venture, I’m available as a resource.

Please don’t hesitate to reach out to explore how my expertise can assist in your professional growth.

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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)