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FDA’s Plan for Modernizing the 510(k) Pathway: What Regulatory, Quality & Compliance Professionals Need to Know
As medical device software and other technology continue to advance at a rapid pace, the FDA’s regulatory policies and processes are being forced to evolve to keep pace with innovation.
Instead of basing substantial equivalence on older predicate devices, the FDA is looking for equivalence to a contemporary baseline of objective safety and performance criteria.
Mary Vater, medical device consultant at Medical Device Academy, Inc., will share best practices and tips for preparing and submitting 510(k)s. She’ll discuss common mistakes and the FDA’s current and evolving expectations for submissions. After 90-minutes you’ll know:
This presentation will break down the 510(k) process and let you know what changes you can anticipate for future submissions.
Mary Vater, Medical Device Consultant, Medical Device Academy, Inc.
Mary Vater is an experienced Biomedical Engineer, now serving as a Medical Device Consultant with Medical Device Academy, Inc., specializing in Regulatory Affairs. Mary started her career at a medical device contract manufacturer, wearing several hats during her time in R&D, Engineering, and Quality Assurance. Mary now works on a QA/RA Consulting team called Medical Device Academy. In her first year of consulting, Mary received six 510(k) clearances for her client companies' products, working in the areas of reprocessed medical devices, surgical sutures, software-only medical devices, in vitro diagnostics, and orthopedic implants.
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