FDA compliant quality system to risk-mitigate, develop, and maintain software-based medical systems
US11295261B2 · kind B2 · utility
Assignee
Inventor
Key dates
| Filing date | May 28, 2019 |
| Grant date | Apr 5, 2022 |
| Priority date | — |
| Expiry date | May 28, 2039 |
Classification
- Technology area (CPC G)Physics
- CPC primaryG06Q10/06395
- WIPO fieldComputer technology
- WIPO sectorElectrical engineering
Abstract
Apparatus and associated methods relate to a risk trace matrix engine for managing database associations, in a quality management system (QMS), between risk mitigations and features of a system having a risk-based profile. In an illustrative example, metadata may be created to associate risk mitigations with elements of a product and then metadata may be stored in a database during the design or operating lifecycle of the product, for example. The engine may dynamically build one or more trace matrices for the product design, each matrix associating risk mitigations to elements of the product design documentation. In response to any modifications that may relate to the component's specifications, for example, the engine may retrieve associated metadata and generate notifications prompting for user verification. In various implementations, such engines may advantageously reduce the risk by automatically generating traceability via a matrix of associations between features and components, which may be hardware and/or software components.
Source: USPTO / EPO open patent data. Objective bibliographic and citation counts.