QMS Consulting, Inc.

QMS Consulting, Inc.

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Quality System Auditing, Customized In-House Training, FDA 483 or Warning Letter Response, Remediation, Quality System Development,  QMS Consulting, Inc. can help!   Located near Chicago Illinois, QMS Consulting, Inc. provides expert consulting service assisting medical device companies worldwide to achieve their Quality and Regulatory Compliance goals.

QMS CONSULTING, INC.
1566 West Algonquin Road, PMB 166 * Hoffman Estates, Illinois 60192 USA
 
Phone:  847 359 4456
or 


FDA ENFORCEMENT ACTION
  • Certification Audits
  • 483 or Warning Letter Response
  • Remediation

AUDITING
  • Internal Quality Auditing
  • Due Diligence
  • Supplier Audits
  • FDA Mock Inspections (QSIT- PMA)
  • FDA Readiness 

COMPLAINT MANAGEMENT 
  • Complaint process development, Complaint investigations
  • MDR Reporting

CORRECTIVE ACTION and PREVENTIVE ACTION (CAPA)
  • Process development 
  • Investigations, Root Cause Analysis
  • Effectiveness Checks

SUPPLIER MANAGEMENT
  • Supply Chain Management
  • Risk based Evaluations
  • Supplier performance monitoring

TRAINING
  • FDA Inspection Readiness
  • Corrective Action / Preventive Action CAPA
  • Quality System - GMP / QSR / ISO13485
  • Supplier Controls, Complaint Management and more. 
  • All customized to meet YOUR needs!
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