Services

Thousands of configuration options, both custom and pre-validated.

• Package Design
• Material Selection
• Package Validation (seal validation, aging, distribution simulation)
• Pre-Validated Packaging (QSEAL®)

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

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

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)