ISO 13485:2016 Certification

Certificate No: MD 778370 | Certified by BSI

At Helaxy, quality and regulatory compliance are at the heart of our innovation. We are proud to be ISO 13485:2016 certified by the British Standards Institution (BSI)—a globally recognized standard for quality management systems in the medical device industry.

Scope of Certification:

Our certified Quality Management System covers the:

• Design and development,
• Manufacture,
• Distribution,
• Installation, and
• Servicing

of in-vitro diagnostic reagents, instruments, and software used in the detection and disease management of:

• Infectious diseases
• Cancer markers
• Genetic diseases
• Metabolic diseases

This certification confirms that Helaxy’s operations meet stringent international standards, ensuring that all our diagnostic solutions are safe, effective, and reliable—delivering trust and value to healthcare providers and patients worldwide.