Thorough
Our team’s vast knowledge of domestic and international regulations and standards provides an advantage. With razor sharp focus on use related risk, we can help lead to market approved solutions that are user friendly, safe, and effective.
Usability Engineering Process
We will guide you through the Usability Engineering Process, from identifying real-world user needs and intended requirements to refining user interfaces through iterative design improvements. Our team will conduct usability testing to ensure your product is intuitive, efficient, and satisfying for users to interact with.
User
Research- Gap Analysis
- Contextual Inquiry
- User Needs
- Use Scenarios
- Similar Products
- Known Usability Issues
Requirements
Definition- Usability Engineering Plan
- Use Specification
- Task Analysis
- uFMEA/URRA
- Design Requirements
- User Interfaces Specification
- Risk Control Measures
Iterative
Design- Brainstorming & Ideation
- Define Key Performance Indicators
- Down-Selection
- Concept Refinement
- Detail Design
- Prototyping
- Labeling & Packaging
- Information Design
- Training Materials
- Mitigation Implementation
Verification
Testing- Acceptance Criteria
- Formative Evaluation
New risk found?
Yes NoRisk mitigated?
No YesValidation
Testing- Acceptance Criteria
- Summative Evaluation
- Residual Risk Analysis
Is overall residual risk acceptable?
No YesRegulatory
Submission- Human Factors Engineering Summary Report
- Design History File
- Regulatory Application Package
Revise Requirements
Regulations & Standards
The Battelle HCD Team upholds strict adherence to regulations and standards established by domestic and international governing bodies, including the U.S. Food and Drug Administration (FDA), to ensure medical device products are safe and effective for the intended users in the intended use environments.
We actively monitor regulatory updates, conduct thorough risk assessments, and enforce stringent ISO 13485 quality control measures. By prioritizing regulatory requirements, companies can effectively mitigate risks, prevent costly penalties, and ultimately deliver safe and effective products to consumers.
Usability Regulatory Guidance
Our team's deep industry knowledge and vigilant monitoring of regulations set us apart. From international medical device design to Department of Defense, government, commercial, and transportation/aeronautics, we offer unparalleled expertise to help your device meet diverse regulatory landscapes.
View Case Studies
