Efficiency
Advance from concept to final design with confidence with robust concept execution for medical devices. Rapid prototyping services enable an efficient and cost-effective assessment of the most promising designs.
Customized Testing
Battelle researchers are experienced in innovating unique testing methodologies that are customized to yield a wide-range of actionable data. Our team designs, executes, and provides comprehensive reports to inform safe and effective design decisions that align with your business and meet regulatory requirements.
Formative Evaluation
Battelle’s formative evaluations are conducted throughout the medical device product development process ranging from assessments of early development to proof-of-concept and near commercial equivalent products and systems.
Battelle’s state-of-the-art formative evaluations are used to:
- Verify Use Specifications
- Gain User Feedback & Performance Requirements
- Identify Areas for Opportunity
- Inform Design Inputs
- Inform Down-Selection of Ideations
- Identify and Evaluate Potential Risk Mitigations
Heuristic Evaluations
Heuristic evaluations are usability reviews of existing or potential concept products/system in which a group of subject matter experts examine the user interface against recognized usability principles (heuristics) and medical device industry guidance.
Testing and Evaluation Services
Comprehensive, thorough, successful. Battelle has a proven track record of helping clients prepare their human factors documentation for regulatory submission.
Contextual Inquiry
- Ergonomic measurement and engineering testing
- Focus group facilitation
- Expert reviews
- Co-creation
- Heuristic evaluation
Usability Testing
- Formative testing
- Summative testing
- Simulated environment testing
- Software usability testing
- Label comprehension testing
- Comparative use human factors studies
Support Services
- Risk management
- Specific population recruiting
- Domestic and international studies
- Internal Institutional Review Board (IRB) review
- Work conducted under ISO 13485 certified Quality Systems
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