clinical alarm management

MEDICAL SYSTEM:

ECG Monitor / Defibrillator (Class III)

WORK SCOPE:

Design, implement, and test software changes on a legacy product to address IEC-60601-1, including Alarm Management behavior following a power loss event, and other BASIC SAFETY and ESSENTIAL PERFORMANCE requirements. Produce the relevant IEC-62304 documentation (Class C software) following company's medical design controls and quality processes.

BACKGROUND:

The regulatory bodies in European and Canadian markets are requiring compliance with the IEC-60601-1 2nd edition standard for all new product sales, and the company would like to accomplish this by means of a software only change to minimize development time; the device hardware has extremely limited available free storage, and the file system is quite limited with no crash safety features which means sudden power loss causes loss of data, or data corruption.

RESULTS:

Designed a binary data storage function purpose built for the 2nd edition alarm settings saving and recovery in the event of power loss. The resident flash memory map was modified to allocate a segregated memory partition for alarm management (2nd edition compliance). In order to minimize the change impact, the changes were limited to the Alarm Management subsystem saving significant time in regression testing. Further, automated unit testing simulating power loss sequences was performed to obtain assurance of the safety and effectiveness of the changes made. Finally, all IEC-62304 lifecycle documentation were updated and formally reviewed, including: requirements, design, code, unit tests and integration tests.

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