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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.

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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
Sucesso do Cliente em Destaque

Wright Medical Technology

Driving competitive advantage through PLM

Driving competitive advantage through PLM

NX and Teamcenter help Wright achieve innovation, speed and compliance goals

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An Intelligent Approach to Design Control for Medical Devices

Getting a handle on the number one cause of medical device product recalls and audit observations

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Recursos da Solução

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

O desenvolvimento de produtos orientado por sistemas (SDPD) do Teamcenter reúne o desenvolvimento de produtos de vários domínios (mecânico, elétrico e software) e considerações como custo, confiabilidade e capacidade de manufatura. 

Product Requirements Engineering

O valor dos requisitos não está em capturá-los, mas na condução do processo de desenvolvimento do produto. O Teamcenter aloca requisitos a várias arquiteturas de funções/recursos/produtos de downstream, ao mesmo tempo que gera relatórios, documentação e painéis para gerenciar o processo de requisitos. Você pode criar, visualizar e editar requisitos diretamente de aplicativos familiares do Microsoft Office, incluindo Microsoft Word e Excel. Os requisitos integrados de ciclo de vida permitem processos de desenvolvimento que começam integrados e continuam integrados ao longo de todo o ciclo de vida do produto.

Simulation Management

Gerencie e compartilhe de forma eficiente as simulações do CAE e do sistema com todos os seus tomadores de decisões, a fim de entender melhor o desempenho do produto para oferecer inovações mais rapidamente e com maior confiança.

Software Requirements Management

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

Verification & Validation

As capacidades de verificação e validação de requisitos do Teamcenter ajudam a fechar o ciclo de requisitos, capturando e associando os resultados de verificação e validação aos requisitos, ao mesmo tempo em que permite testes com foco. Com o Teamcenter Requirements Management, os requisitos são incluídos em um processo de ciclo fechado, em que os requisitos estão vinculados à maneira como são verificados e validados (V&V). Como o Teamcenter também inclui gerenciamento de teste e validação, os requisitos podem ser vinculados a casos de teste que os validam.

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