QMS Consulting, Inc.

Quality Management Solutions

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Sue Jacobs 		Quality Auditing, Customized In-House Training, FDA 483 or Warning Letter Response, QMS Consulting, Inc. can help!

Located near Chicago Illinois, QMS Consulting, Inc. provides worldwide consulting service assisting medical device companies achieve their Quality Management System and Regulatory Compliance goals.
 		QMS CONSULTING, INC.
1566 West Algonquin Road, PMB 166
Hoffman Estates, Illinois 60192 USA

1 847 359 4456(office) ~ 1 847 359 4512(fax)
SERVICES PROVIDED BY QMS: Click here to CONTACT QMS
  • Auditing (ISO, FDA QSR)
    - Internal Auditing
    - Due Diligence Assessment
    - Supplier Audits
    - Mock QSIT Audit
    - PMA Audit

  • CAPA
    - In-House Training
    - CAPA file remediation
    - Identify and define data sources
    - Establish action limits
    - Integrate risk management
    - Metrics
    - CAPA Process development
    - CAPA Process reengineering
    - Root cause analysis

  • Complaint Management
    - Complaint file remediation
    - Process development
    - Remediation
    - MDR reporting
  • FDA Inspection Readiness
    - Mock audits
    - Inspection procedures
    - Training

  • FDA Enforcement Action
    - 483 Response
    - Warning Letter response

  • In-House Customized Training
    - Auditing
    - CAPA
    - Quality Management Systems (ISO/FDA)
    - FDA Inspection Readiness
    - Complaint Management