Certifications & Compliance
Internationally recognized quality standards you can trust
ISO 9001:2015
Quality Management System certification ensuring consistent manufacturing excellence.
ISO 13485:2016
Medical devices quality management for regulatory compliance and patient safety.
CE Certification
European conformity marking for medical device market access and trust.
Quality Assurance
Committed to Global Standards
Our quality management system ensures every instrument meets stringent international requirements. From incoming material inspection to final packaging, we maintain full traceability and documentation for regulatory compliance.
- Documented quality procedures and SOPs
- Regular internal and external audits
- Calibration of all measuring equipment
- Complaint handling and CAPA processes
ISO 9001
Quality Management
ISO 13485
Medical Devices QMS
CE Marking
European Conformity for Medical Devices
Request Compliance Documentation
Contact us for certificates, test reports, and regulatory documentation for your market.
Contact Quality Team