How to prepare Your medical device for 510(k) submission
Course length: 1 Day
Facts
Each day 08:30 – 16:30 (8.30 a.m. – 4.30 p.m.)
Background:
A Premarket Notification 510(k) is one of the major pathways for bringing a device to market
Content:
Medical Device classificationOverview of 510(k)s ProgramContent of 510(k)510(k) submission Process510(k) Decisions
Who Will Benefit:
• Quality professionals• Regulatory professionals• Compliance professionals• Design engineers