Associate Director – Human Factors
1:45 PM An Overview of Human Factors for Combination Products: From Initial Planning Through Reporting
- Broad overview of human factors: Regulatory considerations and common challenges in the planning, execution, and reporting of human factors
- Ensuing the safety and effectiveness of human/device compatibility: User interface, instructions and training programs
- Human factors testing, analysis and validation to identify and eliminate issues
- Optimising the design of the product to improve usability outcomes
2:15 PM Workshop C: Human Factors Considerations for Combination Products: Usability and Engineering
he design of a combination product will have a huge impact on whether the product is safe, effective and compliant. Because of this, human factors and usability engineering play a significant role in ensuring product quality and that it meets the requirements for their intended use.
This workshop will guide through the regulation, design strategy, assessment considerations and safety testing to ensure your products are safe, reliable and user centric.
Attend this workshop to:
•Get to grips with the regulatory landscape: What information should be provided, when and how?
•Better integrate design controls and human factors: Creating and implementing a quality system and design control strategy for compliance
•Determine user requirements and translating the outcomes into design outputs
•Gain clarity around formative evaluations and hazard mitigation
•Discuss Human Factors and Safety Testing: Recommendations on approaches for design and validation testing as well as how this differentiates between products