As innovation in medical device design increases, so does the complexity of product development. Companies need to integrate and manage their data in new ways – to understand the status of a project at any time, to discover the effect of a proposed change across the project, and to structure data for regulatory submissions.
This webinar demonstrates how taking a structured approach to data ensures high data integrity, a strong chain of evidence, and improved credibility with regulatory bodies. Examples will be used for:
- Preliminary Hazard Analysis (PHA), Hazard Analysis (HA)
- Use Error Analysis (UEA) / Usability
- FMEA (Application, Design, Process, other): standalone or blended with HA
- Reusable, managed libraries for Hazards, Harms, and all other data items
- Requirements management
- Test management
- Automatic trace matrix generation supporting unlimited levels and data items
Complete the form to get access to the full webinar today.