Sub-project: Quality System

Plan

 

Topic

Post-market Requirements - Quality System, Medical Device Reporting

• Quality System (QS) Regulation Overview and the QS Regulation (21 CFR H-Medical Devices Part 820)

 

Project Description

The goal of this project is to design quality system (QS) regulation processes for the manufacture, packaging, labeling, device evaluation, distribution, complaint handling, record retention, training, auditing, and preparing for governmental inspections.

Contents

• · Standard Operating Procedures
  • Manufacturing Processes
    • Records
    • Changes in Process
  • Packaging Processes
    • Link = CFR 21 § 820.130
  • Labeling Requirements and Methods
    • Link = CFR 21 § 820.120
  • Device Evaluation Methods
  • Auditing
    • Links = CRF 21 § 820.20, § 820.22, and § 820.25
  • Distribution of Devices
    • Link = CFR 21 § 820.160
  • Chain of Custody Forms, Procedures, & Records
    • Links = CFR 21 § 820.60 and § 820.65
  • Complaint Procedure Forms, Reporting Requirements, & Records
    • Link = CFR 21 § 820.100
  • Record Retention Procedures
    • Link = CRF 21 § 820.180, § 820.181, § 820.184, § 820.186, and § 820.198
  • Training of Employees and Record Retention
  • Calibration of Equipment & Record Retention
  • Maintenance of Equipment, Logs, & Record Retention
  • Miscellaneous
    • SOP on Writing SOPs
• Facility Inspections - Manufacturing
• Equipment Inspections
• Documentation of Quality Systems
  • Forms for Inspections
  • Deviations and Corrections
• Outline Standards for a Non-Conforming Product (device evaluation)
  • Links = CFR 21 § 820.90, § 820.80, and § 820.86
• · Adverse Events
  • Handling
  • Forms, Records, and Retention
  • Reporting to Relevant Agencies
  • Response
  • Follow-up Measures
  • Metrics Evaluating Success of Response

 

 

About This Page

This page is maintained by Norman Bayne. It was last updated on 08 January 2006.

The author(s) provide this information as a public service, and agree to place any novel and useful inventions disclosed herein into the public domain. They are not aware that this material infringes on the patent, copyright, trademark or trade secret rights of others. However, there is a possibility that such infringement may exist without their knowledge. The user assumes all responsibility for determining if this information infringes on the intellectual property rights of others before applying it to products or services.

Copyright (C) 2006 Norman Bayne. Copying and distribution of this page is permitted in any medium, provided this notice is preserved.

Back to the Phoenix Home Page