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Contract Services

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)