About us and our rapid test kits
QUALITY AND ACCURACY
Test Kits are 98-99% accurate in detection of sexually transmitted infection. Our Medical Test Kits are manufactured under strict quality controls. Most importantly the ISO 13485 Medical Device Standard
About the ISO 13485 Medical Device Standard
ISO 13485 is the world’s most recognized Medical Device Standard. It is recognised by WHO (World Health Organisation), FDA (Food and Drug Administration, USA), and the European Commission. ISO 13485 is the most rigid global standard in manufacturing, exceeding even those of the FDA.
What ISO 13485 means:
- Quality Management Assurance
- Increased Efficiency
- Supply Chain Performance
- Improved Manufacturing Processes
- Meeting Customer Requirements
- Legal Compliance
- Annual inspection visits by ISO staff to the manufacturing plant.