Our Services

Human Factors & Usability

Ensuring Safe, Effective, and Intuitive Use of Medical Technologies
PTL Solutions offers comprehensive Human Factors (HF) and Usability Engineering (UE) services to help medical device companies bring products to market that are safe, intuitive, and aligned with global regulatory expectations. Our HF practice integrates deep expertise in user research, risk management, design evaluation, and regulatory submission support, ensuring that devices perform as intended in real-world clinical and home settings.

We work across the full product lifecycle—supporting early design decisions, guiding iterative development, and generating the evidence required for FDA, Health Canada, and EU submissions.

Our Human Factors Expertise

End-to-End HFE/UE Support
Our team has extensive experience delivering the full spectrum of human factors activities, including:

  • User Research and Early Development
  • Use-Related Risk Analysis (URRA) & Risk Mitigation
  • Formative Usability Studies
  • HF Validation (Summative) Testing
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Our Team’s Capabilities

PTL’s Human Factors team includes consultants with hundreds of devices and 20+ years of specialized experience in:

  • Human factors engineering for medical and pharmaceutical products
  • Class II and III medical device development, including hardware, software, robotics, and navigation systems
  • Verification & validation (V&V), design control remediation, and MDR transition activities
  • Agile product development, cross-functional leadership, and design quality engineering
  • FDA 510(k), De Novo, Technical File submissions, and associated HF validation
  • Collaboration with surgeons, therapists, nurses, and patients in simulated and clinical environments

Our team members have supported both startups and multinational manufacturers, integrating human factors into broader product development and regulatory strategies. Their combined expertise ensures that PTL can deliver practical guidance, rigorous study execution, and high-quality documentation tailored to each client’s needs.