compliance you can trust.
Sterilization you can prove.

QUALITY ASSURANCE

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

EPA & State Air Permits - Full emissions controls and monitoring

FDA QMSR (21 CFR Part 820) - U.S. regulatory alignment

ISO 11135 - Ethylene oxide sterilization of health-care products

ISO 13485 - Quality management system for medical devices

ISO 14971 - Risk management throughout the sterilization lifecycle

OSHA Standards - Worker health and exposure protection

Lynx Process Control and Validation

PROCESS CONTROL & VALIDATION

Our facilities maintain end-to-end control of sterilization cycles:

Cycle Development & Validation: 1Q/0Q/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.

Lynx Quality Management

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

Questions?

  • These ISO standards govern ethylene oxide sterilization (ISO 11135), quality management systems for medical devices (ISO 13485), and risk management throughout the product lifecycle (ISO 14971). LYNX Medical aligns its sterilization and quality systems with these internationally recognized standards.

  • OSHA is the U.S. Occupational Safety and Health Administration, which establishes requirements to protect worker health and safety. LYNX Medical operates under OSHA standards to ensure proper exposure controls, monitoring, and workplace safety.

  • An EQNS (Environmental Quality Notification System) is a regulatory framework used to monitor and manage environmental emissions and compliance. LYNX Medical maintains active emissions controls and monitoring programs in accordance with EPA and state air permit requirements.

  • Yes. LYNX Medical operates in alignment with FDA Quality Management System Regulation (QMSR, 21 CFR Part 820) and maintains appropriate regulatory registrations as required for its sterilization operations.

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