FALLS CHURCH, Va., Feb. 6, 2019 /PRNewswire-PRWeb/ -- FDA's Plan for Modernizing the 510(k) Pathway **An FDAnews Webinar**
It's becoming increasingly difficult to obtain 510(k) clearances on medical devices.
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 attendees will know:
This presentation will break down the 510(k) process and let attendees know what changes can be anticipate for future submissions.
Meet Your Presenter: 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.
Who Will Benefit:
Webinar Details: FDA's Plan for Modernizing the 510(k) Pathway What Regulatory, Quality & Compliance Professionals Need to Know **An FDAnews Webinar** Wednesday, Feb. 20, 2019, 1:30 p.m. - 3:00 p.m. EST http://www.fdanews.com/planmodernizing510kpathway
Tuition: $287 per site
Easy Ways to Register: Online: http://www.fdanews.com/planmodernizing510kpathway By phone: 888-838-5578 or 703-538-7600
About FDAnews: FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.
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