Stringent Controls To Meet International Quality Certifications, Compliance & Standards:
- ISO 13485
- GMP System
- US FDA Quality System Regulation
- CE Marking
- ASTM D3578
- ISO 11193-1
- AS/NZS 4011
- JIS T 9113
Control and Validation to Ensure Maximum Adherence to Quality Standards at Each Step of the Manufacturing Process.
- Quality assurance programs for all stages of production to ensure against defects.
- Environmental controls to limit any airborne contamination.
- Lot numbers control for traceability and accountability for each production batch.
PRODUCTION AND QUALITY CONTROL PROCESS