Complaint File and Medical Device Reporting Requirements
 Complaint File and Medical Device Reporting Requirements
The Complaint File and MDR Requirements module was designed to provide personnel with a knowledge
and understanding of FDA’s 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
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.
Click on the picture to enlarge.
RCA & CAPA Preview PDF
Contact QARA Compliance Connection at (813) 784-8457
or Email: info@qaracc.com for
pricing and ordering information or click
here for our order form.
|
