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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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Design control for medical devices

Learn how growing complexity and regulatory oversight challenges medical device development.

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
Wyróżniona historia sukcesu klienta

Wright Medical Technology

Driving competitive advantage through PLM

Driving competitive advantage through PLM

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

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Webinar na żądanie | 28 min.

Inteligentne oprogramowanie dla urządzeń medycznych zapewniające optymalną kontrolę nad projektem

Nasze innowacyjne rozwiązania umożliwią Twojej firmie z branży urządzeń medycznych tworzenie inteligentnych projektów

Nasze innowacyjne rozwiązania umożliwią Twojej firmie z branży urządzeń medycznych tworzenie inteligentnych projektów

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Możliwości rozwiązania

Explore the key areas of this solution.

Software Issue & Defect Management

Track all possible and reported failures. Plan and assign tasks to mitigate risk.

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 Management & Publishing

Product documentation can be expensive to produce, and have a long life – and can be very complex, even having to meet stringent standards. Done right, documents can be very profitable, especially when they support the service business. Teamcenter can help your teams create specifications, analysis reports, 2D/3D illustrations, spreadsheets, test results, and technical publications that are aligned with product changes to reduce the time and cost of development while improving document accuracy and effectiveness.

Manufacturing Process & Data Management

Program and Project Management Manage and execute medical device design projects via a unified digital platform.

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.

RapidAuthor Interactive Visual Content

Highly descriptive technical publications can be very profitable, especially when they help manufacturing and service teams be more productive. RapidAuthor for Teamcenter extends your investment in engineering design data by reusing that content directly in technical documentation. CAD and PLM XML content is converted directly to text and 2D/3D graphics and animations, to give people a better sense of how products work and what decisions need to be made to manufacture and service them.

Software Requirements Management

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

Software Test & Quality

Design, coordinate, and track all your test management activities in a single, collaborative QA environment.

Testing

Enhance testing processes and boost productivity and product innovation

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