Here is the latest revision (CURRENT: REV11) of our traceability matrix for the pipette project!

Revision History

1. REV11 (4/27/23): Minor updates to the design verifications and design inputs for 1.9 and 2.6 based on comments.
2. REV9/10 (4/20/23): Updated design verifications to update user needs (some verifications require user judgement, so surveys were implemented to meet these needs). Removed ISO standard verification due to lack of status as a medical device.
3. REV8 (4/4/23): Updated design outputs, verification, and validation in a first draft for future examination.
4. REV7 (3/28/23): Updated user needs and design inputs to meet task failure analysis
5. REV6 (3/27/23): Updated user needs and design inputs to meet FMEA requirements.
6. REV5 (3/09/23): Added preliminary user needs and design inputs for regulatory standards (subject to change, due to lack of application in vivo or in clinical settings).
7. REV4 (3/06/23): Included numbers for design inputs for higher specificity
8. REV3 (2/27/23): Added preliminary design inputs by translating user needs into technical limitations/goals. Also interviewed mentors across the BME lab to identify user needs and inputs, edited and expanded user needs accordingly (See Design Input/User Need 1.7, taken directly from user interviews).
9. REV2 (2/22/23): Fixed embed/link access, added more user needs to other sections of the matrix as shown.
10. REV1 (2/21/23): Init