CDx Software Documentation for PMA

MEDICAL SYSTEM:

Companion Diagnostic Device (Class III)

WORK SCOPE:

Conduct a software risk analysis for a companion diagnostic software application, based on the ISO-14971 standard, and generate all related IEC-62304 documentation, including SOUP documentation and validation. Support PMA submission providing input into TRFs and traces to conformance artifacts in the design history file.

BACKGROUND:

A previously developed CDx software application was used to validate a CDx application, and the company intends to proceed with a PMA submission, and requires support for software risk management aspects for a Class III medical device accessory. The preliminary validation of the CDx identified some change requirements in the data analysis parameters.

RESULTS:

Reviewed life cycle documentation for existing CDx software application, and performed a gap analysis for IEC-62304 compliance. Updated existing documentation for PMA submission (plans, requirements, design, and test protocols), and implemented required changes to data analysis parameters per design input requirements.

Created missing risk management documentation including a software risk analysis identifying risks, mitigations, and traceability to risk control requirements per ISO-14971 and IEC-80002 standards. Implemented risk control measures and performed structural coverage analysis for critical software items traceable to hazardous situations.

Provided support for PMA submission including summarizing design history records related to software, including: trace matrix, software requirements specification, software architecture specification, detailed design specification, unit test reports (w/ structural coverage data), and software risk analysis.

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