Partnering with you from product development to commercialization through end-of-life.
Thousands of configuration options, both custom and pre-validated.
- Package Design
- Material Selection
- Package Validation (seal validation, aging, distribution simulation)
- Pre-Validated Packaging (QSEAL®)
Supply Chain Management
Managing your supply chain, so that you don’t have to.
- Materials Sourcing
- Supplier Management
- Inventory Management
Assuring your product is identified to meet industry standards.
- Label Development & Printing
- UDI Compliance
- Barcode Generation (Verification & Grading)
- Custom Serialization
- Cloud-Based Label Management
- Compliance to CFR and ISO Labeling Standards
Cleaning & Passivation
Removing manufacturing residuals with validated cleaning processes.
- Cleaning Validation Engineers on staff
- Automated cleaning and passivation
- Product Validations, assessments, and routine monitoring – per current ISO and ASTM standards
- Specialized cleaning for difficult geometry and specialized regulatory requirements
- ISO accredited investigative tools such as FTIR and SEM
- Ultrapure DI water systems
Product Assembly, Kitting & Packaging
Bringing it all together to produce your finished product.
- Surgical Procedure and Accessory Kits
- Soft Tissue Repair Devices
- Single-Use Instruments
- Active Implants
- Spine, Trauma and Reconstruction Implants
- Drug Delivery Devices & Kits
Managing your product sterilization with our certified microbiologists and sterilization scientists.
- Multiple Sterilization Modalities
- Product Validations, Assessments and Annual Revalidations
- QSTERILE® Pre-Validated EtO Sterilization Cycle
- Post-Sterilization Services (LAL, Bioburden, Dose Audits, Cytotoxicity)