- Auditing
- CE Marking and ISO certification
- Design Control
- Design Validation for Medical Devices
- Documentation Management
- Establishment Registration and Product Listing
- FDA 483/warning letter responses
- Good Laboratory Practices (GLP)
- GMP Pharmaceutical Manufacturing
- Equipment Validation
- European Medical Device Directive Compliance
- European Technical Files
- ISO 9000
- Medical Devices
- Metrology/Calibration
- Pharmaceuticals
- Preventative Maintenance
- Process Validation
- Product Complaint Handling/MDR’s/Vigilance
- Product Labeling
- Product Recalls
- Product Submissions/Registrations
- Project Management
- Quality Assurance/Engineering
- Quality System Implementation/Enhancement
- Quality System Regulations (QSR)
- Regulatory Affairs/Submissions
- Regulatory Inspections/investigations
- Risk Analysis (FMEA, FTA)
- U.S. Regulatory Compliance for Medical Devices and Pharmaceuticals
- Standard Operating Procedure Development
- Statistical Process Control
- Supplier Management
- Training/Seminars
- Vendor/Supplier Auditing
Vantage Consulting
International, Ltd.
PO Box 848
Grayslake, IL 60030
(847) 856-0355
webmaster@vantage-international.com