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NANGA PRODUCTS
CODEBEAMER

WINDCHILL RV&S
PARTNER
SERVICES
  • ALM We are the expert for Application Lifecycle Management.
  • PLM Integrated product lifecycle management is already a reality.
  • (MB)SE From approach to implementation: with (Model Based) System Engineering
  • Agile Transformation We enable your digital and agile transformation.
  • Digital Thread Expertise along the entire Digital Thread.

Medical software comes with strict requirements: FDA, EU MDR, ISO 13485, IEC 62304. To stay compliant, your ALM environment must prove it delivers complete, accurate, and auditable records.

NANGA Codebeamer Medical Validation ensures that your Codebeamer system is fully prepared for this challenge. We provide a ready-to-use validation service designed specifically for the Medical Software Engineering Template in Codebeamer.

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Design ohne Titel - 2025-08-26T151806.824

SUCCESS WITH CODEBEAMER

WHY CMV?

Your Problem

In the regulated world of medical technology, using a powerful ALM tool like Codebeamer is not enough – it must also be validated. Without validation, organizations face missing proof of compliance with FDA, EU MDR, and ISO standards. Changes may become untraceable, audit trails inconsistent, and documentation overly manual and error-prone. This uncertainty during audits and inspections leads to higher risk, project delays, and unnecessary costs.

 

Our Solution

NANGA Codebeamer Medical Validation eliminates these challenges. As a specialized validation service for Codebeamer, it ensures that your development environment meets the requirements of 21 CFR Part 11, EU MDR, and IEC 62304. The service covers relevant use cases, delivers automated and manual test cases, and provides complete audit-ready documentation. With this foundation, your processes become secure, traceable, and regulator-proof—without additional burden for your teams.

 

 

TALK TO US ABOUT NANGA CMV

We are here for you

Benefit from our extensive experience in regulated industries and our deep expertise with Codebeamer. Let NANGA SYSTEMS guide you with a holistic approach to medical validation.

Gain insights and real-world use cases that help you achieve compliance faster, reduce risks, and strengthen the reliability of your development environment.

Get in touch with our experts:
Lars Joosten

Lars Joosten

SALES DIRECTOR
January Wygle Rink

January Wygle-Rink

KEY ACCOUNT MANAGER