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Software Verification and Certification for Defibrillator Battery Management Unit
about project
Primedic required a comprehensive verification process, including automated testing and certification documentation preparation for their defibrillator’s battery management unit software.
As a Class III medical device, the defibrillator had stringent requirements for reliability and compliance with the highest industry standards, specifically IEC 62304 and ISO 13485.
The key challenge was ensuring that the battery management system could operate autonomously for three years while maintaining optimal functionality. The defibrillator’s battery condition is critical; any failure could result in incorrect treatment during emergencies.
Tasks
1. Perform software verification to ensure the software meets the high reliability and safety standards required for a IEC 62304 Class C medical device.
2. Develop and execute automated tests to validate the functionality, accuracy, and safety of the defibrillator’s battery management system
3. Prepare certification documents in compliance with industry standards, including IEC 62304 and ISO 13485, ensuring the software meets regulatory requirements.
4. Ensure that the defibrillator operates with precise functionality and maintains safety standards over an extended period (autonomously for up to 3 years).
Results
Recovered Requirements: Successfully reconstructed software requirements from both general descriptions and existing code, creating a clear basis for verification and testing.
Thorough Analysis and Testing: Conducted detailed reviews and testing, leading to the identification of 50+ issues, including 10 critical bugs that were vital for ensuring device safety and performance.
Compliance and Certification: Delivered fully compliant certification documents aligned with IEC 62304 and ISO 13485 standards.
The client successfully obtained a CE certificate, enabling product sales within the EU.
Techstack and standards:
- Technologies: C, VectorCAST, Test automation
- Standards: IEC 62304, ISO 13485
- Domain knowledge: IEC 62304 Level C, Medical device verification
process
Project Implementation
Requirement Capturing and Reviews
The team collaborated with the client to capture detailed software requirements from existing code and high-level descriptions. These requirements were then reviewed to ensure they aligned with IEC 62304 and ISO 13485 standards.
Code Reviews and Analysis
Code reviews were conducted to evaluate the software’s quality and compliance with safety standards. This phase also included analyzing the software’s structure to identify areas needing further improvement.
Automated Testing Implementation
Automated tests were developed and implemented to validate the software’s functionality, reliability, and performance. The testing was designed to cover all critical paths required for a Class III medical device.
Structural Coverage Analysis
The team measured and analyzed code coverage to ensure that the automated tests provided comprehensive verification, meeting regulatory requirements for structural coverage.
Bug Fixing and Iterations
Over 50 issues were identified during testing, including 10 critical bugs. The team addressed these through multiple iterations, refining the software until it met the necessary safety and performance criteria.
Certification Documentation
The final phase involved preparing the necessary documentation for IEC 62304 and ISO 13485 compliance, enabling the client to successfully obtain CE certification for the defibrillator.
review
feedback from
our customer
“The Seaberry Technologies team demonstrated excellent competence in software development and verification according to the IEC 62304 standard requirements.”
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