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
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.
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.
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