革新的でコラボラティブ、かつ連携した新規プログラムの管理
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.
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.
Explore the key areas of this solution.
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.
Avoid copy mistakes, ensure the integrity of data, manage medical device records and provide traceability across entire device lifecycle.
この材料主導型製品設計の時代において、企業が革新的で持続可能な製品を生み出すためには、製品で使用されるすべての材料のライフサイクルを管理することが不可欠です。Teamcenter Integrated Material Managementは、包括的な材料データ管理をエンタープライズ全体に提供し、設計、シミュレーション、コンプライアンス、製造などを含む、製品ライフサイクルのすべての材料面をサポートします。
MBSE within Teamcenter brings together multi-domain product development – mechanical, electrical, and software – and considerations like cost, reliability, and manufacturability.
The value of requirements isn't in capturing them, but in driving the product development process from the customer's perspective. Since requirements are a part of Teamcenter, you can allocate requirements to various downstream functions, features, and product architectures (and vice versa) -- all while generating the reports, documentation, and dashboards to manage the requirements process.
Efficiently manage and share CAE & system simulations to all your decision-makers to better understand product performance to deliver innovations faster and with greater confidence.
Capture and communicate requirements with an integrated platform designed specifically for medical device organizations.
Teamcenter Requirements verification and validation capabilities help to close the loop on requirements by capturing and associating verification and validation results with requirements while enabling focused testing. With Teamcenter Requirements Management, requirements are included in a closed loop process, where requirements are tied to how they are verified and validated (V&V). Because Teamcenter also includes test and validation management, requirements can be tied to test cases that validate them.
Enhance testing processes and boost productivity and product innovation
The value of requirements isn't in capturing them, but in driving the product development process from the customer's perspective. Since requirements are a part of Teamcenter, you can allocate requirements to various downstream functions, features, and product architectures (and vice versa) -- all while generating the reports, documentation, and dashboards to manage the requirements process.
Teamcenter Requirements verification and validation capabilities help to close the loop on requirements by capturing and associating verification and validation results with requirements while enabling focused testing. With Teamcenter Requirements Management, requirements are included in a closed loop process, where requirements are tied to how they are verified and validated (V&V). Because Teamcenter also includes test and validation management, requirements can be tied to test cases that validate them.
The medical device industry is shifting toward country-specific regulatory demands, in-country manufacturing and supply chains, and improved afford...
医療機器がますます複雑化し、規制当局の監視が厳しくなるなか、製品を効率的に製造し、競争力を維持するのは容易ではありません。しかし、規制に準拠しつつ、イノベーションを促進し、市場投入を加速しながらデータ品質を向上する方法は必ずあるはずです。 シーメンスが提供する医療機器向け製品ライフサイクル管理...
Deliver innovation at warp speed with PLM for Medical Devices. Our solution is easy to learn and access with AI-supported usability, secured synchr...
複雑化と規制監督が医療機器開発にもたらす課題について学びましょう。設計管理の重要性と、競争優位性を獲得するための包括的なソリューションについて学びます。
Highlighting the significance of digitalization and the design process for medical device manufacturers.