Peritia offers flexible, on-demand support across all phases of Human Factors.
Human Factors Engineering (HFE) is essential to ensure that your medical device is safe, effective, and intuitive for end users.
Whether you’re preparing for formative studies, validation testing, or regulatory approval, Peritia connects you with seasoned experts who bring deep insight into FDA and international expectations.
Here are a few ways we can help
Strategy & Planning
- Human Factors regulatory strategy.
- Use-related risk analysis (URRA).
- Development of use specifications & user profiles.
- FDA & global regulatory body correspondence to ensure alignment from the start.
- Formative research & usability testing.
Summative (Validation) Testing
- The design process & execution of validation studies.
- Recruitment & test site coordination.
- Study reports aligned with FDA, IEC 62366, & MDR requirements.
- Risk-based justification and documentation for 510(k), De Novo, PMA, & EU MDR submissions.
Documentation & Regulatory Support
From Human Factors Engineering Reports to DHF inputs and usability narratives, we help ensure your documentation is clear, compliant, and complete.
Who We Support
We partner with MedTech innovators at all stages, including:
- Startups navigating first in-human trials.
- Growth-stage companies preparing for FDA submissions.
- Large device manufacturers seeking surge capacity or remediation support.
Why Peritia?
96% Experienced Consultants
Access Human Factors professionals with 10–20+ years in MedTech across Class II and III devices
Integrated Approach
Seamless alignment with your cross-functional teams—Regulatory, Clinical, QA, & R&D
Speed & Flexibility
On-demand resources that scale with your needs & timeline
Regulatory Approval
Experts who know what reviewers are looking for—and how to deliver it
About Peritia
At Peritia, we accelerate life sciences with strategic expertise and solutions, supporting the full product journey—from concept to commercialization. In a rapidly evolving world, we unite experts, innovative thinking, and deep industry insight to provide high-value advisory, strategic, and just-in-time operational support. Our tailored deliverables empower scientific potential, enabling those with whom we work to advance their programs and achieve impactful results.
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