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.

Formara Consulting

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