MedTech Strategist Innovation Summit
About
Date/Time
Date(s) - November 14, 2022 - November 16, 2022 All DayLocation
Hyatt Regency San Francisco Airport1333 Bayshore Highway
Burlingame, 94010
NAMSA invites you to join us at MedTech Strategist Innovation Summit on November 14-16 in San Francisco, CA. This conference will offer a broader and deeper take on the issues and concerns driving the medical device industry today. In a mix of keynote presentation and plenary sessions, bring together some of the leading voices in today’s medtech world to provide both insight and opportunity.
Don’t miss Maria Nyakern’s panel discussion focusing on Commercialization Strategies Post-MD on November 16, 11:00-11:30 AM. Dr. Nyåkern has experience in the medical device industry as a clinical research scientist and entrepreneur across the spectrum of early-stage start-ups to large multi-national organizations. She joined NAMSA through the acquisition of AKRN in March 2022.
COMPLIMENTARY CONSULTATIONS
Visit us at our booth for complimentary 30-minute consultations with NAMSA’s medical device experts throughout the event. We welcome the opportunity to discuss with you the most cost-effective pathways to market based on your unique product development requirements.
Please contact us to reserve your consultation time, or simply stop by the booth in the exhibitor area to meet with us. We hope to see you there!
Speaker
Dr. Maria Nyåkern
Executive Director, CRO ServicesDr. Maria Nyåkern is 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.