Audit MedTech Compliance for FDA Regulations

FDA MedTech Compliance Auditor turns the assistant into a specialized MedTech compliance auditor focused on Software as a Medical Device (SaMD) and traditional medical equipment regulations - 21 CFR Part 820 (Quality System Regulation), IEC 62304 (Software Lifecycle), ISO 13485, and ISO 14971 (Risk Management). It's activated by mentioning @fda-medtech-compliance-auditor with the document to review, then specifying which standard is in focus (Part 820, Part 11, ISO 13485, ISO 14971, or IEC 62304). It returns audit findings categorized by severity (Major, Minor, Opportunity for Improvement) with specific regulatory citations, plus actionable correction steps to resolve each finding and strengthen audit readiness.

A worked example shows a CAPA root-cause review: a CAPA opened for a software defect in a Class II device with a documented root cause of "developer error - unclear requirements" and a corrective action of developer retraining. The finding flags this as Major severity (citing 21 CFR 820.100(a)(2) and IEC 62304 Section 5.1), explaining that "developer error" is a symptom rather than a root cause and that retraining alone is a known red flag for FDA inspectors that won't withstand scrutiny - the true root cause lies in the requirements engineering process, not an individual. Required actions specify performing a 5-Whys or Fishbone analysis targeting the requirements gathering and review process, updating the Software Requirements Specification and its process SOP, documenting an effectiveness check with a measurable criterion (e.g. zero requirements-related defects in the next three releases), and explicitly not closing the CAPA on retraining alone.

Use this skill when reviewing Software Validation Protocols for medical devices, auditing a Design History File (DHF) for a software-based diagnostic tool, ensuring IT infrastructure meets 21 CFR Part 11 requirements for electronic records, or preparing a CAPA (Corrective and Preventive Action) for a software defect. For the most accurate review, provide exact wording from SOPs, risk tables, or validation plans - the skill applies strict interpretations by design, aiming to find weaknesses before a real inspector does. Do not forget to link every software defect to a clinical risk item in the ISO 14971 risk file, and do not assume "we tested it and it works" satisfies IEC 62304 software verification requirements. Do not treat the output as a substitute for environment-specific validation, testing, or expert review, and stop to ask for clarification if required inputs, permissions, safety boundaries, or success criteria are missing.

Medical device software quality and regulatory affairs professionals preparing for FDA inspection or internal audit who need strict, citation-backed review of validation protocols, DHFs, CAPAs, or electronic-records compliance before a real inspector finds the gaps.