OpenRegulatory Template

List of CAPAs

ISO 13485:2018 Section Document Section
8.5.2 (All)
8.5.3 (All)


This list contains all of our Corrective and Preventive Actions (CAPAs).

List of CAPAs

Input Category CAPA ID Date Created CAPA Description Root Cause Date Root Cause Analysis Completed Action (Corrective / Preventive) Date Actions Defined Potentially Adverse Implications Verification Date of Verification Effectiveness Evaluation Date Closed
Usability feedback 1 01-01-2022 No contact details provided as part of product information Missing Test Case for Product Information 02-01-2022 New product release incl. contact details; update test cases 03-01-2022 Release of product version and test case update Number of future complaints related to this issue; review of technical information by Notified Body for completeness

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