Illuminious is proud to announce that our manufacturing facilities have achieved ISO 13485:2016 certification, the international standard for medical device quality management systems. This achievement marks a significant milestone in our commitment to serving the medical device industry with the highest quality standards.
Certification Details
- What: ISO 13485:2016 Medical Device Quality Management System certification
- When: Certification achieved December 2025
- Scope: All global manufacturing facilities
- Impact: Full capability to serve medical device customers worldwide
What ISO 13485 Means for Our Customers 🏥
Regulatory Compliance
FDA and international alignment: Systems designed to meet FDA 21 CFR Part 820 and international medical device regulations.
Risk Management
Risk-based approach: Comprehensive risk management throughout product development and manufacturing processes.
Full Traceability
Complete genealogy: Component-level traceability from raw materials through finished medical devices.
Documentation Control
Comprehensive records: Complete documentation control supporting regulatory submissions and audits.
Our Commitment to Medical Device Quality 💊
ISO 13485 certification demonstrates our unwavering commitment to:
- Consistent quality management: Rigorous quality systems ensuring consistent product quality
- Patient safety: Manufacturing practices that prioritize patient and end-user safety
- Regulatory excellence: Systems designed to meet evolving global medical device regulations
- Continuous improvement: Ongoing investment in quality systems and capabilities
- Supply chain integrity: Qualified supplier programs ensuring component quality
— Dr. Robert Kim, VP of Quality at Illuminious"Achieving ISO 13485 certification represents our commitment to becoming a premier partner for medical device companies worldwide. This certification validates our quality systems and positions us to support innovative medical technology companies from prototype through scale production."
Expanded Capabilities 🚀
With this certification, we can now support medical device customers through the entire product lifecycle:
Collaborative R&D: Work with your engineering team on DfM and DfA for medical devices.
Documentation assistance: Support for 510(k), CE Mark, and other regulatory submissions.
Clean room production: ISO Class 7 clean room facilities for sensitive medical assembly.
Ongoing compliance: Support for vigilance reporting and post-market surveillance.
Your Trusted Medical Device Partner
ISO 13485 certification is a testament to our commitment to quality in the medical device industry. Contact our medical device team to discuss how we can support your next medical technology product.
