Flexible Manufacturing: The Ideal Model for OEMs Requiring Precision
Flexible manufacturing is redefining how OEMs respond to dynamic MedTech markets. It empowers accurate production, without compromising anything—specifically, elements such as governance, traceability, and product excellence. However, not everyone is aware of how it works. In this article, you can discover how this transformative model enables medical device manufacturers to navigate shifting market needs. All […]
Protecting IP When Nearshoring Medical Manufacturing
The importance of IP protection while nearshoring lies in one simple fact: it makes your company unique. In an increasingly competitive market, being different is what sets you apart. Are you going to let someone take that away from you? How can you ensure that your company’s secret sauces remain safe? You may find this […]
The Future of Medical Devices Under USMCA: What You Need To Know
The current USMCA agreement establishes measures that support the medical device manufacturing industry and exports through precise regulatory alignment and tariff benefits. Notable improvements, such as a complete duty-free allowance for qualifying products, unified criteria, reduced costs, and a single audit system, promise to contribute to the sector’s thriving growth. Other key elements, such as […]
Why Class II Medical Devices Require Stricter Validation
FDA validation is mandatory for Class II medical equipment due to its moderate-to-high risk outline. This practice certifies compliance with regulations and the security of medical devices that directly impact patient health. What Sets Class II Medical Devices Apart: FDA validation The FDA institutes specific and strict requirements for these products due to their elevated risk […]
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, […]