Dr. Maria Nyåkern is a clinical research scientist and medical device executive with a broad understanding of the clinical development and commercialization process of medical device technology. Dr. Nyåkern has 15 years’ experience working for medical device start-ups, as well as for global manufacturers like Abbott, Medtronic and Cordis. She has an extensive experience in planning and executing clinical investigations required for regulatory submissions, as well as Post-Market Clinical Follow-Up (PMCF) studies. She also has a solid track record of successfully collaborating with relevant stakeholders, authorities, clinicians and medical device executives, worldwide. In 2017, Dr. Nyåkern established ÅKRN Scientific Consulting, a European CRO offering clinical and regulatory services to the medical device and diagnostic industries. In 2022, ÅKRN and its 40+ employees was acquired by NAMSA.

Dr. Nyåkern’s core competencies include CRO business operations, clinical strategic/optimization planning, clinical evaluation and medical technology business development, as well as 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. She is a renowned speaker and trainer on the topic of clinical evaluation and clinical investigation of medical devices.

Dr. Maria Nyåkern has a strong academic background and international scientific training in Sweden, France, Italy and the United States (U.S.). 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 and European Medical Device Regulations (MDR 2017/745).
• Advising sponsors on strategy for device intended purpose, clinical evaluation, CE mark submissions and 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 (CIPs) according to ISO 14155:2020 for a wide variety of devices
• Overseeing the review of over dozens of medical device clinical evaluation reports (CERs) and performance evaluation reports (PERs)

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
• PMCF for vascular device in the determination of presence or absence of PAD
• First-in-Man (FIM) clinical investigation to assess safety and performance of device to treat resistant hypertension
• FIM clinical investigation 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

• CER transition to 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)
• CER transition MDR 2017/745 for a class IIb device (vescioamniotic shunt)
• Literature Review under MDR 2017/745 for a class IIa/IIb device
• Clinical and regulatory advising on pre-clinical and clinical development for Invasive surgery assistant robot
• CER under the MDR for class IIa Medical Devices (IV solution administration)
• CER under the MDR for class III Medical Devices (breast implant/Tissue Expander)
• CER under the MDR for class III Medical Devices (chemical peeling)