Transform Requirements Engineering into a Fully Integrated Medical Device Development Process

Polarion is widely recognized as a powerful platform for Requirements Engineering and Test Management. But in the regulated medical device industry, product development requires much more than managing requirements alone.

Critical regulatory processes such as:

• Risk Management
• Usability Engineering
• Clinical Evaluation
• Change Management

are deeply interconnected with product requirements and verification and validation testing activities.

In this webinar, we will demonstrate how a fully integrated Polarion platform enables seamless traceability across all these processes, creating a connected digital ecosystem for medical device development.

You will learn how integrated workflows and linked data structures help organizations:

• Ensure regulatory compliance with end-to-end traceability
• Maintain alignment between requirements, risks, usability, clinical evidence and tests
• Improve collaboration between engineering, quality, regulatory, and clinical teams
• Reduce manual effort and audit preparation time
• Analyze the impact of changes faster and more reliably
• Prevent inconsistencies and missing updates during change implementation

We will also showcase how our integrated Polarion solutions go beyond traditional Requirements Engineering by connecting multiple MedTech-specific processes into one unified platform.

This creates a significant added value for manufacturers who want to improve efficiency, scalability, and compliance readiness throughout the entire product lifecycle.

Who Should Attend?

This webinar is designed for professionals in the medical device industry, including:

• Requirements Engineers
• Systems Engineers
• Test & Verification Engineers
• R&D Managers
• Quality & Regulatory Affairs Professionals
• Risk Managers
• Clinical Affairs Teams
• Digital Transformation Leaders
• Polarion Users and Administrators