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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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
Successi dei clienti in primo piano

Cercacor

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Webinar su richiesta

Intelligent Design Control – Risk Management

Intelligent Design Control – Risk Management

Next-Generation Design Control: Watch the third webinar of this three-part series on Intelligent Design Control – Risk Management that addresses post-market surveillance activities.

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Funzionalità della soluzione

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

La soluzione Systems Driven Product Development (SDPD) di Teamcenter consente di combinare i vari domini dello sviluppo del prodotto, ovvero meccanico, elettrico e software, con fattori quali costi, affidabilità e producibilità. 

Product Requirements Engineering

Il vero problema non consiste nel registrare i requisiti, ma nell'utilizzarli per guidare il processo di sviluppo dei prodotti. Teamcenter alloca requisiti alle varie funzioni, feature e architetture di prodotto a valle, consentendo al tempo stesso di generare report, documentazione e dashboard per la gestione di tali requisiti. È possibile creare, visualizzare e modificare requisiti direttamente dalle principali applicazioni di Microsoft Office, inclusi Microsoft Word ed Excel. I requisiti integrati nel ciclo di vita garantiscono processi di sviluppo integrati dall'inizio alla fine, per l'intero ciclo di vita del prodotto.

Simulation Management

Gestisci in modo efficace ed efficiente le simulazioni CAE e di sistema e condividile con tutti i responsabili decisionali, per comprendere meglio le prestazioni del prodotto e accelerare la realizzazione delle innovazioni in tutta sicurezza.

Software Requirements Management

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

Testing

Migliora i processi di test e massimizza la produttività e l'innovazione dei prodotti

Verification & Validation

Acquisendo i risultati ottenuti tramite le funzionalità di verifica e convalida di Teamcenter Requirements e associandoli ai requisiti stessi, sarà possibile chiudere il cerchio su questi ultimi e abilitare test dedicati. Con la gestione dei requisiti di Teamcenter, i requisiti vengono inseriti in un processo a ciclo chiuso, in cui sono associati alle relative modalità di verifica e convalida (V&V). Poiché Teamcenter include inoltre funzioni di gestione di test e convalida, i requisiti possono essere correlati a test case che li convalidano.

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Design Process for Medical Devices

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

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