Medical Device CAPA & 8D — FDA QSR Compliance Guide

Medical Device CAPA and 8D Medical device manufacturers operate under FDA 21 CFR Part 820 (Quality System Regulation) and ISO 13485. Both require a documented CAPA (Corrective and Preventive Action) process. The 8D methodology maps directly to CAPA requirements and is accepted by FDA auditors as a structured problem-solving framework. FDA QSR Clause Mapping to 8D FDA 21 CFR 820 8D Discipline What Is Required 820.70 Production Controls D0 Identify nonconformity, contain affected product 820.100(a) CAPA Procedure D1 Documented procedure, cross-functional investigation 820.100(a)(1) Investigate D2-D4 Data-driven problem description, root cause analysis 820.100(a)(3) Identify Action D5-D6 Verify and implement corrective actions 820.100(a)(4) Verify/Validate D5 Validate CAPA effectiveness with objective evidence 820.100(a)(6) Prevent Recurrence D7 Systemic prevention, FMEA update 820.100(b) Management Review D8 Management sign-off, trend analysis ISO 13485 Additional Requirements ISO 13485 Clause 8.5.2 Corrective Action and 8.5.3 Preventive Action require: Review of nonconformities including customer complaints Determination of causes using structured root cause analysis Evaluation of need for action to prevent recurrence Implementation of actions with effectiveness verification Review of corrective action taken and its effectiveness All of these align with 8D D0-D8. Medical Device-Specific 8D Considerations Risk Management Integration (ISO 14971): D7 must update the device Risk Management File,...