San Emeritus Lifesciences maintains the highest standards of quality, safety, and compliance with international regulations to ensure the best outcomes for healthcare providers and patients.
Internationally recognized certifications and compliance standards
Medical Devices - Quality Management Systems
International standard for quality management in medical device manufacturing
US Food and Drug Administration
Compliance with US medical device regulations and standards
Good Manufacturing Practice
Adherence to pharmaceutical manufacturing best practices
Kenya Bureau of Standards
Local compliance with Kenyan quality and safety standards
European Conformity
Compliance with European medical device directives
Cleanroom Standards
Controlled environment manufacturing specifications
Rigorous quality control and assurance procedures at every stage
Comprehensive testing and verification of all incoming raw materials and components to ensure they meet our strict specifications.
Continuous monitoring and control of manufacturing processes with real-time quality checks at each production stage.
Rigorous final product inspection and testing before packaging and distribution to ensure zero defects.
Complete traceability and documentation of all products throughout the manufacturing and distribution process.
Advanced laboratory testing facilities for microbiological, chemical, and physical analysis of products.
Regular audits, customer feedback analysis, and continuous process improvements to maintain excellence.
Adherence to international and local regulatory requirements
Advanced equipment and expertise for comprehensive product testing
Sterility testing, bacterial contamination analysis, and microbial identification
Chemical composition analysis, purity testing, and contamination detection
Mechanical properties, durability, and performance testing
Long-term stability studies and shelf-life determination
Our quality assurance team is available to discuss our standards and certifications