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Intelligent Design Control

Intelligent Design Control

Complexity in the development of medical devices, especially for smart medical devices that include software and electronics, demands software solutions to establish design controls that orchestrate the design process across inter-disciplinary engineering teams.

Intelligent Design Control is our solution for medical device companies to become data-driven, model-based, and document smart. Intelligent Design Control increases engineering efficiency and speed across the device lifecycle while avoiding costly errors, quality issues, and recalls.

Complexity in the development of medical devices, especially for smart medical devices that include software and electronics, demands software solutions to establish design controls that orchestrate the design process across inter-disciplinary engineering teams.

Intelligent Design Control is our solution for medical device companies to become data-driven, model-based, and document smart. Intelligent Design Control increases engineering efficiency and speed across the device lifecycle while avoiding costly errors, quality issues, and recalls.

ON-DEMAND WEBINAR

Product development data management, learn from Sartorius AG

Leveraging information for modeling, data management and regulatory requirements

Intelligent Design Control

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The development of modern, complex medical devices is a big challenge, especially for smart medical devices which increasingly use software and electronics to deliver essential therapeutic and diagnostic capabilities. Establishing regulatory-mandated design controls by tracking and tracing the network of user needs, risks, design requirements, and verification and validation testing can become overwhelming without the use of software-based solutions.

The risk of incomplete, incorrect data can lead to errors, quality issues, loss of time, poor performance, and significantly increase the likelihood of recalls. Intelligent Design Control is our holistic solution for integrating requirements and risk management, test planning and execution, and design output management, including Design History Files (DHF) and Device Master Records (DMR).

Enable your medical device company to become data-driven and document smart by powering your design process across mechanical, electrical, and software engineering teams with increased speed and clarity to produce safe high-quality device designs. Furthermore, our smart solution supports devices throughout the entire lifecycle by re-using data and connecting it via digital threads to quickly respond to inquiries during regulatory reviews or sustaining incremental engineering changes.

Intelligent Design Control
Presentación del éxito de nuestros clientes

Cercacor

Healthcare technology innovator uses Polarion software to reduce test creation time by up to 75 percent

Siemens PLM Software helps Cercacor create visibility and accountability across testing programs

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Webinar a la carta | 32 minutos

Intelligent Design Control – Design Definition

Intelligent Design Control

Next-Generation Design Control: Watch the first webinar of this three-part series on Intelligent Design Control – Design Definition that addresses multi-domain product development

Vea el webinar

Funcionalidades de la solución

Explore the key areas of this solution.

Design Output Management

Enable companies to efficiently synchronize all data, domains and functional areas, including secure supplier collaboration. Provide a scalable, best-in-class platform for integrating outputs from all engineering disciplines.

Document Control

Avoid copy mistakes, ensure the integrity of data, manage medical device records and provide traceability across entire device lifecycle.

Materials Data & Lifecycle Management

Material information and how it’s managed can have a profound effect on your product’s lifecycle, and materials data management often plays a role in the success of the product.

Model Based Systems Engineering

El desarrollo de productos basado en sistemas (SDPD) de Teamcenter combina el desarrollo de productos multidominio (mecánico, eléctrico y de software) con aspectos como los costes, la fiabilidad y la capacidad de fabricación. 

Product Requirements Engineering

El valor de los requisitos no radica en su registro, sino en fomentar el proceso de desarrollo de los productos. Teamcenter asigna requisitos a distintas funciones/características/arquitecturas de producto posteriores, todo ello mientras genera los informes, la documentación y los paneles para gestionar el proceso de los requisitos. Puede crear, visualizar y editar los requisitos directamente desde las aplicaciones habituales de Microsoft Office, como Microsoft Word y Excel. Los requisitos integrados en el ciclo de vida permiten un proceso de desarrollo que "empieza integrado y continúa integrado" a lo largo de todo el ciclo de vida del producto.

Simulation Management

Gestione y comparta de forma eficiente las simulaciones de CAE y sistemas con todos los responsables de la toma de decisiones con el objetivo de comprender mejor el rendimiento de los productos para ofrecer innovaciones más rápido y con mayor confianza.

Software Requirements Management

Capture and communicate requirements with an integrated platform designed specifically for medical device organizations.

Verification & Validation

Las funciones de verificación y validación de los requisitos de Teamcenter ayudan a cerrar los ciclos de requisitos registrando y asociando los resultados de la verificación y validación con los requisitos a la vez que permite la realización de pruebas. En la gestión de los requisitos de Teamcenter, los requisitos se incluyen en un proceso de ciclo cerrado, donde los requisitos están vinculados a la forma en que se verifican y validan (V&V). Dado que Teamcenter también incluye una gestión de pruebas y de validación, es posible vincular los requisitos con casos de pruebas que los validen.

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Design Process for Medical Devices

Highlighting the significance of digitalization and the design process for medical device manufacturers.