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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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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
精选客户成功案例

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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在线研讨会回放

Intelligent Design Control – Verification & Validation

Intelligent Design Control – Verification & Validation

Next-Generation Design Control: Watch the second of this three-part series on Intelligent Design Control – Verification and Validation through test case management, contextualization, and claim substantiation.

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解决方案功能

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 中的系统驱动型产品开发 (SDPD) 融合了多领域产品开发(机械、电气和软件)以及成本、可靠性和工艺性等考虑事项。 

Product Requirements Engineering

需求的价值并不在于确定相关需求,而在于通过其推动产品开发流程。 Teamcenter 为各种下游功能/特性/产品架构分配需求,同时生成报告、文档和仪表板对需求流程加以管理。 您可以通过熟悉的 Microsoft Office 应用程序(包括 Microsoft Word 和 Excel)直接创建、查看和编辑需求。 借助生命周期集成需求,可在整个产品生命周期内实现“开始集成,保持集成”的开发流程。

Simulation Management

高效管理 CAE 和系统仿真并将其共享给所有决策制定者,以便充分了解产品性能,进而更加自信地加快创新交付。

Software Requirements Management

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

Verification & Validation

Teamcenter Requirements 的核实和验证功能将通过捕获核实和验证结果,并将这些结果与要求进行关联同时支持重点测试来实现对要求的闭环管理。 使用 Teamcenter Requirements Management 时,要求已包含在闭环流程中,其中要求与它们的核实和验证 (V&V) 方式紧密关联。 由于 Teamcenter 也包含测试和验证管理,要求也可与验证它们的测试案例紧密关联。

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Design Process for Medical Devices

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