The Food and Drug Administration's (FDA) 510(k) Guidance document outlines the steps medical device companies follow to bring a product to market. MasterControl will increase your chances for success. Ensure all materials and tasks for every market are complete, compliant and on time.
Losing a design history file (DHF) or any other FDA 510(k) content results in costly setbacks. Keep all documents in order, reduce risks and never omit any important submission items, tasks or deadlines.
510(k) submissions go much smoother when you have immediate access to all your data history, documents and artifacts. It’s also valuable to have a complete view of change control, CAPA, training, etc. processes and records.
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