A med device startup discusses their product’s successful product life cycle journey to FDA approval. BraveHeart created a biometric data-gathering wearable device that allows medical staff to monitor a patient’s EKG patterns remotely through IoT technology.
CEO Steve McCalmont explains how MasterControl Spark’s digitized quality management system (QMS) streamlined the device’s submission process. Thanks to our quality and compliance BraveHeart achieved FDA approval for its product in just 27 days after submission.