How do you scale fast and stay compliant in a regulated industry?

For early-stage medical device companies, the pressure to build compliant systems while accelerating toward market launch can be overwhelming. Harmonic Bionics—a robotics startup turned commercial manufacturer—found themselves navigating this exact challenge. As they transitioned from research roots to a full-scale medical device operation, they needed more than checklists and folders. They needed clarity, structure, and control—without slowing down innovation.

This case study dives into how Harmonic Bionics took ownership of their quality processes, stood up a compliant QMS in record time, and created a system that empowered both QA and engineering teams to collaborate without confusion.

Inside the case study, you'll discover:

• What challenges the team faced as they shifted from academic lab to FDA-regulated manufacturer
• Why traditional QMS platforms fell short—and how Unifize proved to be the right fit
• How they built compliant processes for document control, change management, and NC/CAPA tracking—without external consultants or IT-heavy systems
• What happened when quality conversations moved into the system, rather than around it
• Tangible results like reduced change approval cycles, faster audits, and smoother team onboarding

If you’re building a compliant, scalable QMS from the ground up—or trying to fix one that’s holding your team back—this story offers a clear example of how to do it smarter.

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