Products & Markets
Medical devices and components for critical care and specialty markets
Manufacturing Capabilities
RexMed manufactures certified, high-quality medical devices and assemblies for OEMs, hospitals, and specialized distributors.
Our product lines span infusion therapy, ophthalmology, parenteral nutrition, urology, and more—supporting regulatory pathways for Class I and II devices across the U.S. and Mexico.
With flexible manufacturing technologies, validated processes, and integrated packaging solutions, we ensure product performance, manufacturing control, traceability, and speed to market.
Key Benefits
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Comprehensive Method Selection
Covers EtO, gamma radiation, e-beam, steam autoclave, and hydrogen peroxide plasma, depending on material and device sensitivity. -
Process Validation per ISO Standards
Includes Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), aligned with ISO 11135, ISO 11137, and ISO 17665. -
Microbiological Testing
Supports bioburden testing and bacterial spore challenges to establish reliable sterilization parameters. -
Traceability and Lot Control
Implements dose audits, biological indicators, and monitoring systems to ensure ongoing process control. -
Labeling and Shelf-Life Testing
Addresses packaging compatibility, expiration labeling, and validation of shelf life through accelerated and real-time aging.
Ophthalmic Diagnostic
Urology
IV Therapy
Parenteral Nutrition
Cardiology
Airway Management
Surgical Catheters
Drug Delivery Systems
Ready to scale your medical product line with confidence?
Explore how RexMed’s certified manufacturing technologies and cross-border operations can support your next device with precision, traceability, and speed-to-market.