FDA Compliant Quality System to Risk-Mitigate, Develop, and Maintain Software-Based Medical Systems

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.

Wireless Telemetry Auto Tuning For Torque Measurement System

A torque measurement system that includes a rotor device and a stator device can perform automatic tuning to improve the initial tuning performed during design and assembly. The stator device can include a variable capacitive

Vibrational Alarms Facilitated by Determination of Motor On-Off State in Variable-Duty Multi-Motor Machines

Apparatus and associated methods relate to a vibrational sensing system (VSS) including an accelerometer and a data processor, which determines an “operational state” of a mechanical drive unit, the processor further employing the “operational state”

Virtual Mask Fitting System

Apparatus and associated methods relate to determining a fit-quality metric for a mask/face combination based upon a calculated dead-space volume between a virtual mask and a virtual face virtually aligned so as to create an

Voltage Regulator with Piecewise Linear Loadlines

Apparatus and associated methods relate to providing a piecewise loadline having a number of segments with different slopes and selecting a segment of the piecewise loadline based on an output current of a power supply.