Invention Grant
- Patent Title: FDA compliant quality system to risk-mitigate, develop, and maintain software-based medical systems
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Application No.: US16423981Application Date: 2019-05-28
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Publication No.: US11295261B2Publication Date: 2022-04-05
- Inventor: Ryan Douglas
- Applicant: Ryan Douglas
- Applicant Address: US MN Stillwater
- Assignee: Ryan Douglas
- Current Assignee: Ryan Douglas
- Current Assignee Address: US MN Stillwater
- Agency: Thompson Patent Law
- Agent Craige Thompson; Timothy D. Snowden
- Main IPC: G06Q10/06
- IPC: G06Q10/06 ; G06F16/22 ; G06F16/25 ; G06F16/907

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.
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