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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
主なユーザー事例

Wright Medical Technology

Driving competitive advantage through PLM

Driving competitive advantage through PLM

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

詳細情報

オンデマンド・ウェビナー

インテリジェントな設計調整 - リスク管理

インテリジェントな設計調整 -  リスク管理

次世代設計調整: インテリジェントな設計調整ウェビナーシリーズ (全3回) の第3回 市販後監査に対処するリスク管理編を視聴

ウェビナーを見る

ソリューションの機能

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

Teamcenterのシステム駆動型製品開発(SDPD)が、機械、電気、ソフトウェア面でのマルチドメインの製品開発とコスト、信頼性、生産性を統一化します。 

Product Requirements Engineering

要件の価値はただ単に要件を満足するということにあるのではなく、製品開発プロセスを促進させることです。Teamcenterは要件をさまざまな下流機能/フィーチャ/製品アーキテクチャーに割り当てます。それと同時にレポート、ドキュメント、ダッシュボードを生成して要件プロセスを管理します。Microsoft WordやExcelなどの使い慣れたMicrosoft Officeアプリケーションから直接要件を作成、表示、編集できます。ライフサイクル統合要件を活用すると、製品ライフサイクル全体にわたって「統合を開始し統合を維持する」開発プロセスを実現できるようになります。

Simulation Management

CAEおよびシステムシミュレーションを効率よく管理し、製品パフォーマンスがよりよく理解されるように、すべての意思決定者と共有して、自信を持ってより速くイノベーションを展開します。

Software Requirements Management

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

Verification & Validation

Teamcenterの要件検証および妥当性確認機能を使用して、検証と検証結果を取得し、要件と関連付けることで要件のループを閉じ、より集中的な試験を行うことができるようになります。Teamcenter要件管理では、要件をクローズド・ループ・プロセスに含め、要件を検証および妥当性確認(V&V)結果と結びつけます。Teamcenterには、試験および検証管理機能もあるため、要件を、検証するテストケースに結びつけることもできます。

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