Germantown, MD, USA (October 01, 2019) – On September 25th, at the 2019 TFDA Seminar for Pre-marketing Regulatory Review of Smart Medical Devices in Worldwide Countries, Amarex Taiwan COO, Dr. Chia-Hua Maggie Ho, gave a keynote presentation addressing the application of, and current US FDA regulatory trends for, AI/ML-based SaMD. Dr. Ho outlined the potential risks and benefits involved with smart medical device product development, and highlighted how Amarex can help with the regulatory approval process. Dr. Ho stated that because of the numerous benefits offered by AI/ML products, SaMD approval increased by 400% within the past month, and the FDA is calling for industry feedback while modifying their traditional regulatory pathway to devise a potentially new regulatory framework for AI/ML-based SaMD. Typical to all other health-related products, risk/benefit analysis and other risk-related categories for AI/ML SaMD play a major role in developing a regulatory pathway for these products. Dr. Ho further explained that while the current FDA regulatory pathway requires “locked” AI/ML algorithms that discard learning strength, based on Amarex’s solid experience with 510(k) and de novo applications, along with considerable experience working closely with the FDA, we can help our clients take advantage of this regulatory pathway to obtain FDA approval for their game-changing AI/ML-based SaMD within the digital healthcare field.

To view the full presentation, visit https://www.youtube.com/watch?v=Osxn0smI338#t=0s.

About Amarex Clinical Research

Amarex is a global, full service Contract Research Organization (CRO), whose leadership team has significant expertise conducting biomedical research, and whose combined experience includes the design and conduct of several hundred clinical research projects in many therapeutic indications. Amarex provides comprehensive services in Project Management (Phase I-IV, BE/BA, PK/PD), Regulatory Affairs (FDA Applications and meetings, Applications to International Health Authorities, GxP Compliance Audits), Clinical Operations, Adaptive Study Designs, Statistical Analysis, Data Management, Medical Monitoring, Safety and Pharmacovigilance, and General Consulting. Amarex can take your product through the entire approval process, from creating the regulatory approval strategy, to conducting trials, to writing the marketing approval application. Join our growing list of clients with approved products. Amarex provides high quality and cost efficient services. For more information visit www.amarexcro.com.

Contact:
Patrick J. Burke
Business Development
patrickb@amarexcro.com
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301 528 7000
www.amarexcro.com