Quality and certification - validated at every step
Quality Performance Metrics
99.8%
Product Quality Rate
96.5%
Customer Satisfaction
98.2%
On-Time Delivery
100%
Regulatory Compliance
International Certifications
ISO 13485:2016
Medical Device Quality Management
Valid until: 2025
Key Requirements:
- Design and development controls
- Risk management processes
- Regulatory compliance framework
- Continuous improvement protocols
CE Marking
European Conformity
Valid until: 2026
Key Requirements:
- EU MDR 2017/745 compliance
- Essential safety requirements
- Authorized representative in EU
- Post-market surveillance
WHO GMP
Good Manufacturing Practices
Valid until: 2024
Key Requirements:
- Clean room facilities
- Validated manufacturing processes
- Personnel training programs
- Documentation control systems
WHO GMP
Good Manufacturing Practices
Valid until: 2024
Key Requirements:
- Clean room facilities
- Validated manufacturing processes
- Personnel training programs
- Documentation control systems
MDR-2017
Medical Device Regulation
Valid until: Ongoing
Key Requirements:
- Clinical evidence requirements
- Unique device identification (UDI)
- Enhanced post-market surveillance
- Increased manufacturer responsibilities
Quality Control Processes
Incoming Material Inspection
All raw materials undergo rigorous testing before production
- Certificate of analysis verification
- Physical and chemical testing
- Microbiological assessment
- Quarantine until approval
In-Process Quality Control
Continuous monitoring during manufacturing processes
- Real-time process monitoring
- Statistical process control
- Environmental monitoring
- Equipment qualification
Final Product Testing
Comprehensive testing before product release
- Performance verification
- Stability testing
- Packaging integrity
- Label accuracy verification
Post-Market Surveillance
Continuous monitoring of product performance in the field
- Customer feedback analysis
- Adverse event reporting
- Performance trending
- Corrective action implementation
State-of-the-Art Facilities
Our manufacturing and testing facilities are designed to meet the highest standards of cleanliness, precision, and regulatory compliance.
Manufacturing Facility
- Chennai, India
- 15,000 sq ft
Key Requirements:
- ISO Class 7 Clean Rooms
- Automated production lines
- Environmental monitoring
- Validated HVAC systems
Quality Control Laboratory
- Chennai, India
- 15,000 sq ft
Key Requirements:
- Analytical testing equipment
- Microbiological testing suite
- Stability testing chambers
- Reference standard storage
Quality Documentation
Our Quality Promise
We are committed to delivering diagnostic solutions that healthcare professionals can trust. Our quality management system ensures every product meets the highest standards of safety, efficacy, and reliability.