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Systems Engineering Services for Excellence

Medical Device Design

Systems Level Architecture and Design

Requirements Management

Design Documentation involves crucial elements such as Interface Definition and Process Definition, which encompasses everything from prototyping to final design. Our approach ensures adherence to IEC/ISO standards and FDA regulations, reflecting our commitment to reliable services and systems engineering that exemplifies technical excellence.

Requirements Management

Systems Level Architecture and Design

Requirements Management

Requirements authoring involves gathering the Voice of the Customer and documenting User Needs to ensure reliable services. This process includes requirements domain allocation for both hardware and software within the context of systems engineering. Furthermore, maintaining traceability and establishing a robust verification and validation strategy are essential steps to uphold technical excellence.

Systems Level Architecture and Design

Systems Level Architecture and Design

Systems Level Architecture and Design

Architecture and design documentation play a crucial role in delivering reliable services within systems engineering. Utilizing modeling techniques like SysML and UML, we ensure technical excellence in our design processes.

Medical Device Risk Management

Medical Device Risk Management

Systems Level Architecture and Design

Achieving ISO 14971 compliance is essential for organizations that prioritize reliable services in their product development. Utilizing techniques such as Failure Mode Effects Analysis, Fault Tree Analysis, and Preliminary Hazard Analysis showcases a commitment to systems engineering and technical excellence.

Design Reviews

Medical Device Risk Management

Technical Writing

Design Review Process with reliable services includes independent 3rd party participation and the involvement of Independent Subject Matter Experts, ensuring systems engineering practices that uphold technical excellence.

Technical Writing

Medical Device Risk Management

Technical Writing

Our reliable services in document creation, remediation, and maintenance are backed by a commitment to technical excellence and systems engineering.

Tradeoff Analysis

Sensors and Actuators

Tradeoff Analysis

The decision process, employing methods such as the Pugh matrix and Kepner-Tregoe, is essential in systems engineering to ensure reliable services and achieve technical excellence.

Fluidics

Sensors and Actuators

Tradeoff Analysis

Our reliable services include flowpath design and pressure/flow analysis, ensuring that we meet the highest standards of systems engineering. We also focus on component specification, such as pumps and valves, while incorporating technical excellence in our mixing/deaeration and disinfection strategies.

Sensors and Actuators

Sensors and Actuators

Sensors and Actuators

Our reliable services encompass sensor and actuator design and development, alongside the specification of these components. We prioritize systems engineering in our component selection process, ensuring a thorough verification of functionality and performance that reflects our commitment to technical excellence.

Prototyping

Extracorporeal Blood Handling

Sensors and Actuators

Our reliable services in prototype design, combined with rigorous benchtop testing, ensure technical excellence in all our projects. We also prioritize thorough documentation of prototyping results to support our systems engineering approach.

Extracorporeal Blood Handling

Extracorporeal Blood Handling

Extracorporeal Blood Handling

The safety and efficacy analysis is essential for ensuring reliable services in various sectors. By leveraging systems engineering principles, we can achieve technical excellence in our evaluations.

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