ISO 13485
Medical Device Quality Management System Standard
Setting the Standard
ISO 13485 represents the gold standard in medical device quality management systems. It's more than a certification—it's our commitment to excellence in every device we produce.
Comprehensive quality management system specific to medical devices
Risk management throughout product lifecycle
ISO 13485:2016 Certificate
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Our Commitment
At ErythrosLight, maintaining ISO 13485 certification reflects our unwavering dedication to quality. Every process, from design to manufacturing, adheres to the most stringent international standards, ensuring our devices meet the highest levels of safety and efficacy.