U.S. Deliveries: The Competitive Advantage of Border Manufacturing
U.S. Deliveries: The Competitive Advantage of Border Manufacturing Border manufacturing in Ciudad Juárez, supported by a logistics hub in El Paso, is transforming how U.S. OEMs receive medical devices. This setup offers numerous benefits, including rapid deliveries, improved transit times, and increased product availability. The result is faster market access, seamless logistics, and reliable medical […]
Exporting Medical Devices from Mexico: What OEMs Need to Know
The medical device industry is undergoing rapid change. Global trade shifts, supply chain risks, and cost pressures are prompting OEMs to reassess their production locations. For many, Mexico has become a strategic hub for efficiently manufacturing and exporting medical devices. Whether you are an established healthcare brand or a medical device OEM preparing to scale, […]
Nearshoring in MedTech: Reduce Lead Times and Boost Compliance
Does your company work with nearshoring in Mexico? Excellent! This business strategy offers significant benefits, including more flexible labor laws and lower production costs. Any company would want to operate under this model. However, some companies encounter problems when transferring their products to North America. Don’t worry; in most cases, these problems are due to […]
Medical Device Label Traceability: A Must-Have for OEMs
UDI labelling is not only a mandatory requirement but also a key factor in maintaining competitiveness. Currently, the healthcare industry requires precise adherence to regulatory standards and agility across various production stages. Why Border Manufacturing Gives OEMs Strategic Advantage Each delay impacts compliance with UDI labelling regulations. One of the main challenges for medical device […]
How to Minimize Medical Device Recalls with End-to-End Traceability
End-to-end traceability is a comprehensive system of identification for medical devices throughout the supply chain, enabling faster recall responses, operational continuity, and post-market compliance. It is based on an accurate and individual identification of units, from the manufacturing process through delivery to the final consumer. Exact and detailed individual identification of defective units helps minimize […]
Medical device traceability: Total control from raw material to customer
In the medical device industry, a single missing record can have severe consequences. Manufacturers face strict regulations, high customer expectations, and the critical responsibility of protecting patient safety. That is why RexMed delivers complete device traceability, covering every step from raw material procurement to final delivery. This system ensures every component and process is documented, […]
FDA Audit Readiness: Preparing Your Manufacturing Line
FDA audit prep is crucial for manufacturing lines to maintain regulatory compliance and avoid costly delays. Therefore, here are the key areas that audits focus on, along with steps to prepare for meeting the audit requirements. Understanding FDA Audit Priorities Knowing the priorities of inspectors is crucial for preparing adequately for an FDA audit. The […]
ISO 13485: What Every OEM Should Demand from a Medical Device Manufacturer
ISO 13485 standard is an international guideline that sets an essential obligation for medical device manufacturers. Understanding its principles and requirements not only enhances the supply chain but also reinforces confidence in critical medical care products. Why ISO 13485 Certification Is Non-Negotiable for OEMs ISO 13485 standard is a vital warranty for OEMs (Original Equipment […]