Lifesaving Defibrillation Therapy Innovation

Updates to Existing Device Needed for U.S. Market Entry

Enhancing Patient Outcomes with Advanced Defibrillation Therapy

MedAcuity partnered with the client’s in house engineering team to resolve a large software defect backlog. Through thorough testing and quality assurance, the team identified and addressed key issues, while also creating essential regulatory documentation to ensure compliance with industry standards. This collaboration streamlined the development process, enhanced software functionality, and ensured regulatory compliance.

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Defibrillation Detail Photo

project snapshot

SITUATION

  • Manufacturer needed to update its popular combination manual defibrillator device with AED, currently selling in overseas markets, for release in the U.S.
  • Market window was closing as the project fell behind schedule due to operational performance gaps

Challenges

  • The in house engineering team, new to the product, had limited knowledge of IEC 60601-1 3rd Edition requirements.
  • As a result, they struggled to identify necessary testing and certification needs, develop a comprehensive test plan, and effectively implement it.
  • The growing backlog of defect fixes, testing, and certification requirements quickly outpaced the team’s ability to address them in a timely and efficient manner.

SOLUTION

  • MedAcuity provided first-hand knowledge and understanding of IEC 60601-1 3rd Edition requirements and how to apply them to the development effort
  • Performed debugging and bug fixes, integrated a new tool for code coverage and analysis reporting, and completed a First Article Inspection of the device
  • Developed and reviewed test procedures (unit, integration, and regression)

Results

  • Software defect backlog was significantly reduced
  • Executed test runs to fully assess updated device and documented results to illustrate compliance
  • Updated design documents for design history file
  • Updated defibrillator was much closer to satisfying the quality and safety criteria needed for U.S. release

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