We design compliant and robust systems that reduce risks, solve problems and support future growth.
Libra Medical has installed many Quality Assurance Systems and has upgraded already installed Quality Assurance Systems that have passed multiple quality system audits by the Notified Body and the FDA.
Full Quality System SOP Design: QSR and ISO 13483
- Change Control System
- Design Control System
- Risk Management System
- CAPA System
- Complaints, MDR and Vigilance
- Vendor Management