Solutions
End-to-end solutions tailored to your medical device lifecycle
A clear roadmap to success
Rexmed offers a comprehensive portfolio of integrated services and solutions that support every stage of the medical device lifecycle.
From design and development to production, sterilization, and distribution, our collaborative approach ensures regulatory compliance, operational efficiency, and full traceability across global healthcare markets.
Product Design Services
From concept to regulatory-ready design
Our design services help OEMs and startups develop compliant and manufacturable medical devices. We combine functional design principles with regulatory insight to ensure readiness for FDA and COFEPRIS pathways.- Regulatory-driven design for Class I and II devices
- Aligned with ISO 13485 and FDA requirements
- Supports seamless scale-up and technical documentation
- Reverse engineering services under our capability's portfolio.
Process Development
Validated processes for consistent quality
We develop lean, validated manufacturing processes that bridge the gap between product design and scalable production. Our focus is on minimizing risk while meeting global quality standards.- Accelerates time-to-market with lower risk
- Ensures compliance with ISO 13485 and Good Manufacturing Practices
- Enables high-volume production with reproducible results
Prototyping
Fast iterations, early validation
Our prototyping capabilities enable quick and effective testing of form, fit, and function. We help identify design flaws early, improving confidence and accuracy before clinical trials or manufacturing.- Reduces development time and cost
- Validates usability and performance
- Accelerates design freeze and transfer readiness
Lab Testing
Validation through data and compliance
Rexmed’s lab testing services support performance verification, regulatory validation, and product reliability. We provide analytical testing to ensure compliance across your product’s lifecycle.- Component and material analysis
- Process and product verification
- Supports FDA/COFEPRIS audits and documentation
New Product Introduction (NPI)
From pilot builds to validated production
Our NPI services ensure a controlled and compliant transition from development to production. We coordinate IQ, OQ, and PQ material sourcing, and scalable infrastructure to meet market demands.- Reduces risks during ramp-up
- Maintains regulatory control at every stage
- Supports supply chain integration and traceability
Global Transfers
International transfers, compliant execution
Rexmed facilitates global product transfers with regulatory alignment and validated procedures. Our cross-border expertise enables smooth transitions across facilities in Mexico and the U.S.- Compliant IQ/OQ/PQ validations
- Complete documentation and tech transfer
- Supports dual regulatory frameworks (FDA / COFEPRIS)
Sterilization Management
Validation through data and compliance
Rexmed’s lab testing services support performance verification, regulatory validation, and product reliability. We provide analytical testing to ensure compliance across your product’s lifecycle.- Component and material analysis
- Process and product verification
- Supports FDA/COFEPRIS audits and documentation
Supply Chain Solutions
Smart logistics and regulatory alignment
Rexmed integrates logistics, material management, and regulatory oversight to maintain a lean and responsive supply chain. With storage and distribution hubs in El Paso and Juarez and deep understanding in the customs process, we ensure continuous flow.- End-to-end traceability and customs clearance
- IMMEX-certified supply chain with dual-country visibility
- Vendor and KPI management aligned with OEM expectations
Let’s review your specs together
Partner with Rexmed for compliant, scalable medical device solutions.