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The Future of Quality and Regulatory for SaMD
About This Webinar
Software as Medical Device (SaMD) is a class of medical software designed to carry out one or more medical functions without the need for actual hardware. According to MarketWatch, global market size for SaMD is projected to reach USD 7365.1 million by 2027, up from USD 596.3 million in 2020.
Join industry experts from ICS and Greenlight Guru to discuss:
• Recent updates and changes in SaMD
• Regulatory and quality considerations in growing technologies including AI, mobile and cloud
• Three steps to take today to prepare for the future
Categories:
SCIENCE & TECH
Who can view: Everyone
Webinar Price: Free
Featured Presenters
Regulatory Project Manager
Magda Kocot is a Medical Project Manager at ICS. She has hands-on experience in design and development, production and certification of medical devices class II and III. She is a Biomedical Engineer with extensive quality and medical devices regulation knowledge, including Quality Management System ISO13485, MDR 2017/745, risk management process, software development life-cycle and electrical medical devices regulations.
Regulatory Project Manager
Geoff Pollard is a Regulatory Project Manager at ICS. Prior to joining ICS Geoff was a Senior Project Manager for Cedars-Sinai Medical Center’s Artificial Intelligence in Medicine program, where he was responsible for regulatory compliance of a market leading class IIa software-only medical imaging device. With over 20 years of experience at Cedars-Sinai, Geoff served as the management representative and was responsible for obtaining and maintaining ISO13485 and MDSAP certifications, five 510(k) clearances and two CE Marks.
Medical Device Guru
Wade Schroeder is a Medical Device Guru at Greenlight Guru with a noticeable enjoyment of medical device product development processes. As an electrical engineer by trade, he began his career developing medical exam procedure chairs and later designing IVD devices. He has been a risk management enthusiast since the beginning and enjoys helping customers develop design processes that their team can be proud of and enjoy. He believes the best part of working with customers is helping them implement a culture of true quality within their team.
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