HUMAN FACTORS / USABILITY ENGINEERING
Ensure the timely, effective, and compliant execution of human factors, risk management, and design activities in your project in line with IEC 62366-1.
STUDY MANAGEMENT SERVICES
We help you selecting the most suitable study supplier for your particular needs and fully manage the completion of the study in line with the current applicable standards while ensuring the results can be seamlessly integrated into your risk management process.
USE-RELATED RISK MANAGEMENT
Identify and control your product’s use-related risks and ensure regulatory compliance in line with ISO 14971.
HARD- & SOFTWARE USER INTERFACE DESIGN
Develop innovative design solutions and effective user instructions and training materials that are systematically optimised towards use-related safety, effectiveness, and user acceptance.
TEST SAMPLE & EQUIPMENT DEVELOPMENT
Test and optimise potential design solutions and critical parameters as early as possible during development and before changes require substantial resources.
HUMAN FACTORS RESEARCH & USABILITY STUDIES
Understand your users and their needs and see how your solutions are going to perform in real life. Systematically leverage the results to optimise safety, effectiveness, and user acceptance.
DOCUMENTATION & REGULATORY SUPPORT
Prepare your documentation, pre-meeting packages, and submissions with confidence. Leverage our expert support in interacting with health authorities.
HUMAN FACTORS VALIDATION
Collect the required evidence of your product’s use-related safety and effectiveness to inform regulatory review in line with ISO 13485 (EU) and 21 CFR Part 820.30 (USA).
TAILORED TRAINING SERVICES
Systematically and effectively build-up your human factors engineering, use-risk management, user interface design, and regulatory resources.