Contract Services Request Information
Contract Solutions to Support Your Business
- 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.
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.
Certified Engineering Team
- Black belt (Lean Sigma Academy)
- Lead Auditor (IRCA certification).
- Lean Manufacturing (Lean Sigma Academy)
- SPC – (Minitab Certification)