Edith Maverick Folger
Principal Software QA Engineer
Edith Maverick Folger has been working in the medical biotech field for more than 25 years. She is currently with Boston Scientific, in Lowell, MA, as a principal software QA engineer in design quality assurance. Folger works with both medical product software/firmware validation, and internal process software/firmware validation.
Usability and Hazard Analysis
Usability studies gather structured users’ input for the design of both safe and popular products. Early usability studies give valuable input, but later usability verification and validation protocols demonstrate that targets were met for compliance (IEC 62366). Usability validation tests the user-faced usability requirements, and the results provide input (confirmation/mitigation) into the project’s risk management file.
Edith Maverick Folger of Boston Scientific will provide an introduction into the regulations around usability/human factors and how they fit within the Quality System Risk Management structure for successful product launch.