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
Click to view full certificate
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.
Understanding ISO 13485 for Medical Devices
ISO 13485:2016 is the internationally recognized standard for quality management systems specific to medical device manufacturing. Unlike general quality standards, ISO 13485 focuses exclusively on the unique requirements of medical device design, development, production, and post-market surveillance.
For our SciLight Pro and Laser Pro Mask, this certification ensures every device undergoes rigorous quality control from initial design through final delivery. Our quality management system covers all aspects of production, including supplier management, design controls, and continuous improvement processes.
The standard requires us to maintain comprehensive documentation for every step of our manufacturing process, implement robust risk management procedures, and conduct regular internal audits. This systematic approach guarantees consistency and reliability across our entire product line, supporting our FDA 510(k) clearance requirements.
Key Quality Management Processes
Our ISO 13485 certification encompasses critical quality management processes that directly benefit our customers. These processes ensure that every ErythrosLight device meets or exceeds performance specifications while maintaining the highest safety standards.
Design & Development Controls:
- Systematic design verification and validation
- Clinical evaluation of wavelength efficacy
- Risk analysis throughout development
- Design change control procedures
Production & Service Controls:
- 100% inspection of critical components
- Calibrated test equipment verification
- Traceability of all components
- Post-market surveillance program
Global Recognition and Compliance
ISO 13485 certification is recognized worldwide as the benchmark for medical device quality management. This certification is essential for accessing international markets and is a prerequisite for many regulatory approvals, including our CE Mark for European distribution and MDSAP certification for multiple international markets.
Our certification is maintained through annual surveillance audits conducted by accredited third-party auditors. These audits verify our continued compliance with all ISO 13485 requirements and drive continuous improvement in our quality systems. Learn more about our quality philosophy and commitment to excellence.
Certification Details: Our ISO 13485:2016 certificate covers the design, development, production, and distribution of photobiomodulation therapy devices. Certificate number and expiration date are displayed on the certificate image above. Regular audits ensure ongoing compliance with all standard requirements.
What This Means for You
When you choose ErythrosLight devices, you're selecting products manufactured under one of the world's most stringent quality management systems. ISO 13485 certification provides assurance that every device has been produced with meticulous attention to quality, safety, and performance.
This certification translates directly to product reliability, consistent therapeutic outcomes, and comprehensive customer support. Our quality management system ensures that whether you're using our devices for professional treatment or home therapy, you can trust in their safety and effectiveness.