Getting a Device to Market When Class Designation is Evolving
Wed. February 6| 1:15 PM - 2:00 PM | 210B
Show: MD&M West 2019
Track: MD&M West: Product Development & User-Centered Design
Focus: Design & Product Development
Badge Type: Paid
Incorporating device design and human factors into regulatory strategy has proven to be effective in gaining the right type of regulatory approval, especially if your product is moving from Class I through to Class III designation. During the early product development stages, a regulatory strategy needs to begin formulation when a device "go/no go" decision is being made. In this session, you'll learn how to work with your regulatory and quality team members to plan a phased regulatory strategy that is based in device design and human factors engineering from the earliest point in the research through the development of design controls.
Topics to be covered include:
- Understanding the principals behind the regulatory requirements for human factors usability and usability testing
- Exploring how design and human factors can influence regulatory strategy
- Industry examples demonstrating how using design and human factors appropriately can create a positive regulatory strategy
