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Allowing you to focus on your device
CLEAR STRATEGIES FOR PACKAGING ENGINEERING, LABELING, AND QUALITY SYSTEMS
Medical Device Packaging
Quality Management System Development
Quality Management System Development
- Packaging Design
- Specification Development
- Verification/Validation
- Compliance
- Remediation
- Sterilization
- Cold Chain
Quality Management System Development
Quality Management System Development
Quality Management System Development
- Design Controls
- Change Management
- CAPA
- Supplier Controls
- Complaint Handling
- Non-conformances
- Process Control
- Equipment and Calibration
- Training
Labeling
Quality Management System Development
Strategic Initiatives
- Content Design
- Label specification
- Instructions for use
- Localization
Strategic Initiatives
Quality Management System Development
Strategic Initiatives
- Due Diligence
- Business Integration
- Independent Review
- Certification (ISO13485, MDSAP, MDR/IVDR...)
- Audit Preparation and Hosting
- Deficiency Response
- Quality Improvement
- Root Cause Analysis