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.
Hoffman Estates, Illinois 60192 USA
 
Phone:  847 359 4456
or 


FDA ENFORCEMENT ACTION:
Certification Audits, 483 or Warning Letter Response, Remediation, FDA Team Preparation and Coaching
AUDITING: 
Internal Quality Auditing, Due Diligence, Supplier Audits, FDA Mock Inspections (QSIT- PMA), FDA Readiness, Gap Assessments
COMPLAINT MANAGEMENT: 
Complaint process development, Complaint investigations, MDR Reporting

CORRECTIVE ACTION and PREVENTIVE ACTION (CAPA): 
Process development, Risk-based CAPA Initiation, Investigations, Root Cause Analysis, Effectiveness Checks

SUPPLIER MANAGEMENT:
Risk-based Supplier Evaluation, Supplier Management, Supplier Monitoring

TRAINING:
FDA Inspection Readiness, Supplier Controls, Complaint Management and more ... customized to meet YOUR needs!

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