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Complaint File and Medical Device Reporting Requirements

  Complaint File and Medical Device Reporting Requirements

Complaint File and Medical Device Reporting Requirement The Complaint File and MDR Requirements module was designed to provide personnel with a knowledge and understanding of FDAs complaint file 21 CFR 820.198 and Medical Device Reporting (MDR) 21 CFR 803 requirements for manufacturers. It is a must for any individuals involved in the complaint handling and adverse event reporting process. The module also includes a sample complaint process flowchart, sample complaint form, MedWatch form and Baseline Reporting form. Click on the picture to enlarge.





 

Root Cause Analysis & CAPA

  Root Cause Analysis & CAPA

Root Cause Analysis & CAPA The Root Cause Analysis and CAPA module was developed for individuals or teams involved with or responsible for determining corrective and preventive action in order to prevent problems from recurring. The RCA and CAPA module is formatted to provide personnel with a complete understanding of the FDA QSR and ISO 9001 and ISO 13485 CAPA requirements. The requirements are illustrated using the FDA Quality System Inspection Technique (QSIT) and the Six Step Method. Various techniques and examples of root cause analysis are also discussed to facilitate effective corrective and preventive action.
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RCA & CAPA Preview PDF



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