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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.

ON-DEMAND WEBINAR

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

On-Demand Webinar | 32 minutes

Product development data management, learn from Sartorius AG

Document management in medical device

Leveraging information for modeling, data management and regulatory requirements

Watch the webinar

Solution Capabilities

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

MBSE within Teamcenter brings together multi-domain product development – mechanical, electrical, and software – and considerations like cost, reliability, and manufacturability.

Product Requirements Engineering

The value of requirements isn't in capturing them, but in driving the product development process. Teamcenter allocates requirements to various downstream functions/features/product architectures -- all while generating the reports, documentation, and dashboards to manage the requirements process. You can create, view and edit requirements directly from familiar Microsoft Office applications, including Microsoft Word and Excel. Lifecycle Integrated requirements enables "start integrated, stay integrated" development process across the entire product lifecycle.

Simulation Management

Efficiently manage and share CAE and system simulations to all your decision-makers to better understand product performance to deliver innovations faster and with greater confidence.

Software Requirements Management

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

Testing

Enhance testing processes and boost productivity and product innovation

Verification & Validation

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.

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