Services

Managing Your Product’s Complete Lifecycle

Partnering with you from product development to commercialization through end-of-life.

Thousands of configuration options, both custom and pre-validated. Learn more
Managing your supply chain, so that you don’t have to. Learn more
Assuring your product is identified to meet industry standards. Learn more
Reducing biological contaminates with validated cleaning processes. Learn more
Bringing your patient solution together to produce a finished product. Learn more
Managing your product sterilization with our certified microbiologists and sterilization scientists. Learn more

Packaging Expertise

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

Labeling

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

Sterilization Management

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)