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

Learn More

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
Presentación del éxito de nuestros clientes

Wright Medical Technology

Driving competitive advantage through PLM

Driving competitive advantage through PLM

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

Más información

Webinar a la carta

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.

Ver el webinar

Funcionalidades de la solución

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

En esta era del diseño de productos basado en los materiales, es de vital importancia gestionar el ciclo de vida de todos los materiales utilizados en los productos para que su empresa pueda crear productos innovadores y sostenibles. La gestión integrada de materiales de Teamcenter permite una gestión global de los datos de los materiales en toda la empresa y es compatible con todos los aspectos de los materiales del ciclo de vida del producto incluidos el diseño, la simulación, el cumplimiento y la fabricación.

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 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.

Simulation Management

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.

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.

Design Process for Medical Devices

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