Aerospace & Defense
Innovation and collaborative, synchronized program management for new programs
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.
Our solutions unified an end-to-end platform to establish traceability to prove compliance, simplicity, and cost effectiveness.Learn More
Quality, risk, and compliance are critical to achieving project objectives during first-time testing.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/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 for 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 efficiency, speed and clarity to produce safe, high quality device designs. Furthermore, our solutions support 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.
Medical device product development is a highly integrated and regulated process. Implementation of solution-based requirements tracking requires attention to a variety of nuanced topics.When presented with the task of tracking the many conceptual relationships in a project of this type, the initial software solution of choice tends to be traditional two-dimensional text systems. This paper outlines why our digital enterprise solution is the best option for your medical device organization.
Explore the key areas of this solution.
Manage and execute medical device design projects via a unified digital platform.
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.
Maximize profit margins by simultaneously increasing revenues and decreasing costs – launching you to new levels of growth and profitability.
Capture and communicate requirements with an integrated platform designed specifically for medical device organizations.
Manage risk and eliminate the likelihood of errors and product recalls with early-stage issue detection and complete traceability.
Create and manage test cases and link them to their corresponding work items such as requirements, change requests or other test cases.
Avoid copy mistakes, ensure integrity of data, manage medical device records and provide traceability across entire device lifecycle.
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.
Execute phased design processes from feasibility studies through to production, service and support, including lifecycle change management. Create and maintain DHF and DMR records, and manage the design transfer process.
Integrate digital simulation in design and manufacturing processes to provide digital evidence for verification and validation.
Optimize the entire value chain through the use of digital twins, virtual representations of the device and its manufacturing processes.