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Contract Solutions to Support Your Business

 

Contract Manufacturing

  • 2,000 square ft of Manufacturing area, ISO class 8 Cleanroom (equivalent to class 100,000 per obsolete FED STD 109E).
  • Quality Management System based on FDA´s 820 CFR (QSRs) and certified in ISO 13485:2003.
  • World class manufacturing facilities.
  • Top Management with over 50 years of experience in Medical device manufacturing
  • Process Capabilities: Packaging (Pouch/Tray sealing), Ultrasonic Welding, RF Welding, UV adhesive bonding and Solvent bonding.
  • Direct and indirect personnel working under Good Manufacturing Practices, experienced in the manufacture of medical devices.
  • A total of 7,320 hours of labor capacity per week.

 

Service Features

Quality comes first.

  • DHR (Device History Record) documentation for each lot processed.
  • Personnel certification.

Reprocessing and sorting of material

  • Inspection method validation through Gauge R&R and Attribute Agreement Analysis.

Manufacturing Process & Engineering Services

  • Equipment qualification (IQ/OQ/PQ).
  • Equipment validation.
  • Assembly method validation.
  • Statistical techniques for process validation
  • Updating of Technical Documentation.
  • New product introduction.
  • Automation.

Certified Engineering Team

  • Black belt (Lean Sigma Academy)
  • Lead Auditor (IRCA certification).
  • Lean Manufacturing (Lean Sigma Academy)
  • ASQ-CQE
  • SPC – (Minitab Certification)