Medical device human factors and usability consulting
We help medical device companies develop medical devices that are safe, user-friendly, and MDR and FDA regulatory-compliant.
Our services
We provide end-to-end medical device human factors and
usability engineering consultancy services.
Usability testing
Conduct an expert review, formative usability test, or human factors (HF) validation summative usability test in compliance with MDR and FDA.
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Risk analysis
Develop a medical device task analysis and use-related risk analysis (URRA) aligned with ISO 14971 and IEC 62366.
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Human factors documentation
Develop regulatory-compliant usability and human factors engineering documentation aligned with IEC 62366 and FDA.
Learn moreAbout us
Human Factors Insight is a global medical device human factors and usability engineering consultancy. Our core mission is to make human factors engineering accessible to companies of all sizes, from agile startups to global medical device manufacturers. We believe that safe and intuitive medical device design shouldn’t be a luxury but a fundamental requirement.
We ensure full regulatory compliance with IEC 62366 and FDA’s final Human Factors and Usability Engineering Guidance, supporting both Europe MDR and United States FDA pathways such as 510(k), De Novo and PMA submissions.
Exclusive focus on medical devices
Experience in FDA and MDR regulations
Senior human factors expertise
Global participant recruiting network
Extensive medical device portfolio
Transparent and accessible HFE services
15+
Years experience
Specialized in medical human factors
1000+
Formative and summative
Usability test sessions conducted
100+
Medical devices approved
Successfully cleared FDA and MDR
Testimonials
“Human Factors Insight organized, managed, and conducted our summative usability test in the United States. They provided clear human factors guidance to ensure we met FDA regulatory expectations.”
Project Manager at Medical Device Startup
“Human Factors Insight conducted a formative usability test of our wearable device with a high level of professionalism and expertise. They were a reliable partner every step of the way.“
Regulatory Lead at Large Medical Company
“We contracted Human Factors Insight to support the full usability engineering process for our medical device. They delivered high-quality work and were significantly cost-effective and flexible.“
Marketing Director at Medical Device Company
Case study
Supporting the design of a safe, intuitive, and user-friendly medical wearable device.
Learn how we supported the redesign of a medical wearable device to reduce use errors by 85% and achieve FDA clearance.
85%
Use error reduction
6 months
To FDA clearance
Global
Launch succes
Expertise
Human Factors Insight has experience in a wide variety of medical devices and complex systems, including but not limited to:
- Auto-injectors (AI)
- Pre-filled syringes (PFS)
- Blood glucose monitors (BGM)
- Drug delivery inhalation devices
- Insulin patch pumps
- Software as a medical device (SaMD)
- Diagnostic imaging systems
- Hemodialysis systems
- Wearable medical devices
- Hemodynamic systems
- Implant devices
- Airway clearance systems
- Endoscopic systems
- Incontinence systems
- Preventive stroke treatment kits
- Laboratory immunosupressants kits
- Ostomy pouching systems
- Surgical instruments
- Operating room (OR) systems
- Medical mobile applications
- Negative wound pressure therapy systems
- Dental systems
Insights
View our most recent insights and knowledge sharing on human factors and usability engineering.
-
The difference between a formative and summative usability test
Read more: The difference between a formative and summative usability test -
Key requirements for a medical device summative usability test
Read more: Key requirements for a medical device summative usability test -
The benefits of early Human Factors Engineering (HFE) Integration In Medical Device Development
Read more: The benefits of early Human Factors Engineering (HFE) Integration In Medical Device Development
How can we help?
Schedule a free consultation or request a quote for your human factors and usability engineering needs.
Contact Us
sheldon@hf-insight.com
Call Us
+31 6 25 33 96 77
Where we operate
Globally