Lifesaving Defibrillation Therapy
Updates to Existing Device Needed for U.S. Market Entry
Healthcare technology leader needed strategic and technical guidance to update existing defibrillator device for U.S. market entry.
MedAcuity closely partnered with client’s in-house engineers to identify and address large software defect backlog, conduct testing, and create required regulatory documentation.
- 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
- In-house engineering staff, new to the product, had limited knowledge and understanding of IEC 60601-1 3rd Edition requirements
- Unable to identify testing and certification needs, build a test plan, and implement the plan
- Growing backlog of defect fixes, testing, and certification needs were more than the internal team could tackle in a timely, effective manner
- 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)
- 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