How to Achieve Full Traceability in Medical Device Development with Codebeamer ALM

 

Developing a medical device is a high-stakes process. From the first concept to market approval, every decision, test, and requirement must be documented. Why? Because traceability isn't just helpful—it's required. Regulatory bodies like the FDA and ISO demand full visibility across your development lifecycle.

That’s where Codebeamer ALM comes in. This powerful Application Lifecycle Management (ALM) platform is designed to help medical device companies track, manage, and trace every aspect of their product development process—all in one place.

Let’s explore how Codebeamer enables end-to-end traceability and why it’s critical for success in the medical device industry.

Why Traceability Matters in Medical Device Development

Medical devices aren’t just gadgets—they’re life-saving tools. Ensuring safety, performance, and compliance is essential.

Here’s why traceability is non-negotiable:

• Regulatory Compliance: Standards like FDA 21 CFR Part 820 and ISO 13485 require manufacturers to track requirements, risks, and test results.

• Risk Management: Traceability helps identify issues early, reducing costly recalls or failures.

• Audit Readiness: With full traceability, your documentation is always ready for inspection.

• Faster Time-to-Market: Efficient tracking and reporting can help speed up development timelines.

Did you know? Missing traceability links are one of the most common reasons for FDA warning letters in the medical device industry.

The Challenge: Manual Processes and Disconnected Tools

Many organizations still use spreadsheets, emails, and outdated systems to manage development. These tools don’t offer a clear view of how requirements relate to risks, tests, or changes.

That leads to:

• Missed connections between requirements and test cases

• Difficulty proving compliance

• Inefficient collaboration between teams

The result? Increased costs, delayed approvals, and higher risk of non-compliance.

Codebeamer ALM: One Platform for Complete Traceability

Codebeamer ALM is purpose-built for complex, regulated product development—especially in the medical device space.

Here’s how it supports full traceability:

 Requirements Traceability

Capture and link requirements across all development stages. From user needs to system specs, every requirement is connected.

• Supports live linking and version control

• Tracks changes and history automatically

• Enables bi-directional traceability

 Risk and Test Management

Codebeamer integrates ISO 14971-compliant risk management tools with your requirements and testing processes.

• Map risks to mitigations and test cases

• Link verification and validation results

• Use templates tailored to medical devices

 Audit Trails and Electronic Signatures

Stay compliant with FDA 21 CFR Part 11 using built-in electronic signatures and secure audit trails.

• Every change is logged

• Review and approval workflows included

• Ready-to-use compliance templates

Real-World Example: How Codebeamer Helps Medical Teams

A medical device company developing a smart insulin pump used Codebeamer to:

• Link 150+ requirements to test cases and risk controls

• Manage design changes across multiple teams and sites

• Pass an FDA audit with zero findings

Their team saved over 30% of development time thanks to automated traceability and real-time collaboration.
Learn more about our ALM services to help you implement tools like Codebeamer successfully.

Integrated Compliance, Quality, and Collaboration

Unlike point solutions or manual processes, Codebeamer centralizes everything:

• Design Controls

• Regulatory Documentation

• Quality Assurance Processes

• Team Collaboration

And since it’s built with flexibility in mind, it integrates with other tools like Jira, GitHub, and Jenkins, making it ideal for hybrid hardware/software development environments.

Read more: Jira or Codebeamer? Why Jira Falls Short in Regulated Projects

Key Benefits of Using Codebeamer for Medical Devices

Here’s a quick summary of what you gain:

• End-to-end traceability from requirements to release

• FDA and ISO compliance support

• Risk and test management in one platform

• Audit-ready documentation and workflows

• Improved team alignment and development speed

Get Started With Better Traceability Today

Traceability isn’t just a checkbox—it’s a competitive advantage. With Codebeamer ALM, you can confidently manage your product lifecycle, reduce risk, and stay compliant.

Ready to transform your development process?

Contact 3 HTi - PTC's System Integrator and Solutions Support Provider.
Let us help you implement Codebeamer ALM tailored to your medical device needs.