BraveHeart Trusts MasterControl when it comes to their Quality Management System

January 16, 2019

An overview of how a med device startup came up with an innovative idea and brought it to market through the help of an automated solution. BraveHeart CEO Steve McCalmont was moved by the cardiac issues of his elderly father to develop a wearable biometrics device.

The company used an automated QMS to manage quality and compliance throughout the device’s product life cycle. This helped BraveHeart get FDA 510(k) approval for its product in less than one month. 


Read how MasterControl helped Hu-Friedy ensure compliance with FDA's 21 CFR Part 820 Quality System Regulat...

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