Přejít k obsahu

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.

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
Vybrané úspěchy zákazníků

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

Další informace

On-Demand Webinar

An Intelligent Approach to Design Control for Medical Devices

Getting a handle on the number one cause of medical device product recalls and audit observations

Watch the webinar

Solution Capabilities

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 Control

Avoid copy mistakes, ensure the integrity of data, manage medical device records and provide traceability across entire device lifecycle.

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.

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.

Structured Content Management

Quality products mean quality documentation – parts catalogs, training guides, operations, and repair manuals. Teamcenter Content Management provides topic and data module management and a dynamic publishing environment within PLM, enabling your tech writers and illustrators to automate the assembly and publishing of product or service information in multiple languages and formats, specific to your product configurations. The result is effective, product-specific technical publications, and faster time-to-market.

Interested in [[global-preference-center-interest-placeholder]]?

Subscribe to [[global-preference-center-interest-placeholder]] updates

Oops

We're very sorry, but we weren't able to capture your submission. Please try again.

Thanks for signing up! First time subscribing? Be sure to check your email to confirm your subscription.

Design Process for Medical Devices

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