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About Formara Consulting

We partner with medical device companies to make usability a strategic advantage—not a regulatory hurdle. Our focus: ✔ Reduce risk – Minimize use-related hazards and avoid costly recalls ✔ Accelerate approval – Navigate IEC 62366 and FDA Human Factors requirements with confidence ✔ Improve outcomes – Design devices that clinicians trust and patients can use safely Our services include: - Human Factors integration throughout development - Risk management aligned with global regulations - Instructional design - Industrial design At Formara, we believe great design saves lives. That’s why we combine deep Human Factors expertise with practical, real-world insight to help you deliver devices that work for people—every time.

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