Skip to Content

Requirements Management

Requirements Management

Manage complexity and improve quality by understanding the impact of changes across the medical device product lifecycle. Our systematic solutions for building-in the voice of the customer enable medical device companies to capture, manage, verify, and maintain requirements information across the development process for safer, more effective products.

Manage complexity and improve quality by understanding the impact of changes across the medical device product lifecycle. Our systematic solutions for building-in the voice of the customer enable medical device companies to capture, manage, verify, and maintain requirements information across the development process for safer, more effective products.

Requirements Management

Learn More

Capture, maintain, and deliver device requirements to everyone involved in the product development process with our requirements management solutions for medical device companies. Integrate customer needs throughout the product lifecycle by understanding the significance of change management. Our solutions offer companies insight and traceability by integrating requirements into the lifecycle. This efficient and scalable way of delivering successful products ensures all requirements are captured, linked, and maintained in the context of the specific device, thus helping mitigate the risks of non-compliance.

Requirements Management

Solution Capabilities

Explore the key areas of this solution.

Adaptable PLM Foundation

Respond quickly to change from business or market disruptions and collaborate with ease with our web accessible PLM plaftorm for medical devices. Choose from flexible deployment options for fast time-to-value and low cost of ownership.

Apply Product Configuration to Requirements

Participate in all aspects of a controlled medical device development process with our product configuration solutions. Subject all device requirements to the same lifecycle processes, variants, workflows, and access controls for optimum efficiency.

Integrate Requirements Across PLM & ALM

Provide cross-domain requirements traceability to ensure medical device organizations successfully develop mechanical and software-driven electronic systems.

Program Planning & Project Execution

Develop complex medical devices through integrated planning and execution in a single, integrated system. Collaborate and communicate key information among interdisciplinary teams to shorten time to market and enable early-stage issue detection.

Report & Specification Generation

Quickly and easily create standard requirement reports, dashboard views, and device specifications including requirements, traceability, verification, variation, status, and impact analysis for complete visibility into the entire device development process.

Requirements Allocation & Tracelinking

Link device requirements to all aspects of the product definition including: specifications, Bill of Materials, program/project tasks, test cases, 1D and 3D models, manufacturing processes, and more.  This allows insight into change propagation in ways never before possible.

Requirements Capture & Authoring

Embed requirements across the medical device lifecycle with our requirements capture and reuse capabilities. Tie requirements to standard product management processes, including change and workflows, for inclusion in standard reporting and dashboards.

Requirements Change

Participate in standard change management practices either as a requirements change process or at the product change level.  Include device modifications within global change planning to eliminate working from stale requirements.

Software Requirements Management

Effectively gather, author, approve and manage requirements for complex systems across the entire medical device lifecycle.

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.