Expertise

What sets us apart.

We understand the dual role of Human Facotrs in medical device development - crafting a positive user experience for the business and generating sufficient evidence of safe and effective use for regulatory agencies. We combine our passion for great design with our expert industry knowledge to provide a well-balanced solution.

EXPERIENCED WITH REGULATORY EXPECTATIONS—we have developed a dozen approved medical products and crafted the Human Factors submission for each. In addition, we have successfully defended Human Factors evidence during FDA and TUV Quality System audits (a rare qualification).

Current in human factors best practices—we participate in industry conferences and events for continuous improvement. We maintain membership on the AAMI Human Factors Standards Committee where we collaboratively create and maintain industry best practices.

Passion—we are known by the integrity of our relationships with clients, the quality of our work, and the positive experience we create for clients and users.

Best practices.

USENSUS is expert in Human Factors standards, FDA guidance & regulations:

• IEC62366
• IEC60601-1-6
• IEC60601-1-11
• ISO14971
• ANSI/AAMI HE75
• FDA 2011 Draft guidance on Human Factors in Medical Device Design
• FDA 2000 guidance on Human Factors in Risk Management
• 21 CFR 820.30