Custom Manufacturing For Medical Devices

Specializing in early-stage medical devices, our expert team guides start-up companies through all stages of the product development process.

Finished Device Assembly

  • Controlled Assembly
  • Design Verification & Validation Builds
  • Pilot Manufacturing Builds
  • Device Master Record Support
  • Device History File Support

Packaging

  • Pouch Sealing
  • Labeling
  • Finished Boxing
  • Controlled Inventory
  • Packaging Validation Services
  • Sterilization and Batch Release process Facilitation

Clean Bench

  • Laminar Flow Workstations
  • Device Assembly
  • Particulate Free Inspection
  • Implant Processing
  • Clean Material Processing

ISO Certification

  • Quality Management System
  • Audit Support
  • ISO 9001 Pending
  • ISO 13485 Planned by end of 2026