I am a software validation expert with 17 year experience in the medical device industry. My specialty includes but is not limited to: software gap analysis & review, new and modified software validation & remediation, software risk analysis, equipment validation (IQ/OQ/PQ), embedded software verification and validation, test development, execution and reporting. I can also help review, write, and revise software validation processes or procedures to be compliant to 21 CFR Part 820, ISO 13485, 21 CFR Part 11, Annex 11, IEC 62304.