Armed with decades of experience and a mature Quality System, we collaborate with you to ensure your medical device is market-ready and complies to all latest industry regulations.
Our capabilities and experience include:
- Fully integrated Quality System- Diversified & approved international suppliers
- ISO 13485 Medical Devices Quality Management
- ISO 14971 Risk Management for Medical Devices
- CE Mark certification
- FDA 21 CFR 820 compliant
- Device History File
- Device Master Records
- Device History Record
