Compliance you can trust.
Sterilization you can prove.
At LYNX Medical, regulatory compliance and quality management are more than checkboxes—they are the foundation of our partnership with medical device manufacturers. Our sterilization programs are built on ISO 13485 and ISO 11135, aligned with the FDA’s Quality Management System Regulation (QMSR), and supported by environmental and safety controls.
Compliance Framework
ISO 11135 – Ethylene oxide sterilization of health-care products
ISO 13485 – Quality management system for medical devices
FDA QMSR (21 CFR Part 820) – U.S. regulatory alignment
ISO 14971 – Risk management throughout the sterilization lifecycle
EPA & State Air Permits – Full emissions controls and monitoring
OSHA Standards – Worker health and exposure protection
Quality Management System
Our QMS ensures consistency, transparency, and continual improvement:
Document Control: Electronic systems with version control and signatures
Nonconformance & CAPA: Root-cause investigations with effectiveness checks
Change Control: Risk-based assessments tied to ISO 14971 principles
Supplier Quality: Qualification, monitoring, and auditing of critical vendors
Internal Audits & Management Reviews: Regular, structured reviews of QMS performance
Process Control & Validation
Our facilities maintain end-to-end control of sterilization cycles:
Cycle Development & Validation: IQ/OQ/PQ, half-cycle BI methods, and worst-case load configurations
Routine Monitoring: Continuous recording of temperature, humidity, EO concentration, pressure, and exposure time
Requalification: Periodic performance requalification to confirm consistency
Batch Records: Complete, audit-ready documentation with full traceability
All products are sterilized in validated, monitored cycles.