Case Study: BraveHeart Wireless achieves 510(k) approval in seven months with MasterControl

How do you go from concept to 510(k) approval in less than a year

BraveHeart Wireless Inc. is a sub‑50‑employee startup in Nashua, NH that develops continuous, real‑time wearable remote patient monitoring—most notably the Life Sensor Cardiac Monitor that captures heart rate and EKG data. Driven by a goal to save a million lives, the company faced an aggressive time‑to‑market mandate and the full rigors of FDA 510(k) requirements while operating with limited resources and geographically dispersed teams.

BraveHeart implemented MasterControl’s cloud‑based quality management solutions (including supplier, VxT, Sx Quality and Qx modules) to centralize documentation, streamline design control and enable real‑time collaboration across locations. That digital QMS kept all required records audit‑ready, simplified the 510(k) submission process and helped the company achieve 510(k) approval within seven months while becoming ready for audits in about six months.

Braveheart

Steve Mccalmont

Founder and Chief Executive Officer