Human Factors & Technical Writing

MITIGATING RISK by DESIGN

Designing a medical device requires expertise in risk management for regulatory compliance and liability control. Worrell’s Human Factors Engineering team follows strict adherence to the regulatory process using the International Standards and FDA guidances, without sacrificing ingenuity. Though the FDA’s mandate is reason enough to perform HFE tasks, the benefits of these tests extend beyond making a product safer. Worrell’s Human Factors Engineering team conducts usability evaluations to produce more effective, intuitive and inclusive novel features that create competitive advantages and improve overall user experience, as well as creates on-product labeling, instructions for use and training materials.

Key Capabilities

IEC 62366 Compliance

User & Environmental Assessments

Use Case Scenarios

Task Analysis

Usability Specifications

Risk Analysis

Cognitive Walk-Throughs

Formative Testing

Instructions for Use, Training & Evaluations

Validation Testing

Documentation for Regulatory Agencies

Summative Testing

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