QMS Consulting, Inc.

Quality Management Solutions

HomeSue JacobsDownloads & EventsCAPALinks

logo1908956_md.gif

Quality System Auditing, Customized In-House Training, FDA 483 or Warning Letter Response, 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


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

AUDITING
  • Internal Quality Auditing
  • Due Diligence
  • Supplier Audits
  • Mock QSIT/PMA Audit
  • FDA Readiness Åudits

COMPLAINT MANAGEMENT
  • Complaint file remediation
  • Complaint process development
  • Complaint investigations
  • MDR reporting decision

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

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

Corrective and Preventive Action (CAPA)
  • CAPA File remediation
  • Process development 
  • Measurement and metrics
  • Investigations, Root Cause Analysis
  • Effectiveness Checks

Call 847 359 4456 or *EMAIL*
We look forward to hearing from you.