Abstract:
Evidence reveals that bias is a prominent issue in the systematic design of biomedical devices. An example is faulty oximeters that mis-diagnosed patients during the COVID-19 pandemic. Biased devices result in unjust health disparities for individuals of marginalized communities. The current scope of the regulatory landscape does not include a holistic solution to build equity into the medical device development process. However, this presentation proposes a systematic process as the presenters will step through all stages of the medical device design control process according to FDA Quality System Regulations (21 CFR Part 820) and ISO 13485 regulatory requirements. Proposed quality system improvements will provide tools for medical device leaders to be socially responsible in building equitable products to ensure medical devices are designed to diagnose and meet the needs of people in our diverse nation, not just a select few.
https://us02web.zoom.us/j/89127769170?pwd=Ymp6WjFWZW1TZ0tsNTVndXFPRXc5QT09
Meeting ID: 891 2776 9170 Passcode: 915812