If you’re an American business searching for a medical device manufacturer, you don’t have to look across the ocean to another continent — the right solution may be closer than you think. Medical device manufacturing in Mexico is a booming industry thanks to its skilled workforce, high tech facilities, and close proximity to the United States. At Coastline International, we’ve been manufacturing medical devices for our partners since 1982. Here’s what you need to know about the process.
Why Choose to Manufacture Medical Devices in Mexico
Coastline International is ISO 13485 & ISO 9001 certified and FDA-registered and we have the experience and qualifications to provide the premium level of contract manufacturing support. We understand the demands of the industry, which is why we provide both the highest quality output and timely delivery. This means that by choosing to manufacture your medical devices in Mexico, you never need to sacrifice your standards. Instead, you’ll get consistent quality at a lower cost. In fact, our medical device manufacturing services have shown a reduction by 30 percent or more below the cost of other domestic contractors or in-house manufacturing for most of our partners.
We can provide our customers with an end-to-end turnkey solution, including the procurement of components and management of supplier sourcing. Coastline’s pricing and services includes the transport and facilitation of the raw materials and components needed to manufacture your medical devices to our facility in Tijuana, Mexico. Once your medical devices have been manufactured, our well-trained team can perform quality assurance testing, first article inspection, and other qualification services.
Furthermore, as a nearshore manufacturer, you won’t have to deal with the hassle, expense, and long transit times of importing medical devices from overseas. To make the process even easier, we handle all of the logistics involved in exporting the finished goods for delivery to the USA and if needed, transporting medical devices to you or your customers. Coastline International provides materials management, warehousing, tracking, importation and exportation services, and customs processing.
Working with Coastline International allows you to partner with a US company — which includes processing POs and invoices in US dollars and English language — while accessing the high-quality, low-cost manufacturing workforce of the Tijuana region of Baja California, Mexico from our trusted facility that has been providing manufacturing support to well-known international OEMs for 40 years.
By outsourcing your medical device manufacturing to Mexico, you can focus on building your business by doing what you do best.
Coastline International Manufacturing Facilities
We operate several ISO Class 8 clean rooms within our FDA-registered manufacturing facilities, totaling over 9,000 square feet of our 50,000 square foot space. Our medical production is completed to ISO 13485 standards and our capabilities include:
- Manual assembly of components and subassemblies, in addition to finished device assembly
- Secondary manufacturing processes
- Mechanical assembly
- Solvent bonding, ultrasonic welding, RF welding, gluing, bonding, and UV curing
- Friction fit assembly
- Thermoforming
- Clicker press die cutting
- Hot stamping
- Packaging, bagging, and kitting
- Private labeling
- Sterilization
- Soft goods sewing for medical textiles
- Re-work
- Tooling and fixture development
We use lean manufacturing principles to serve our customers in the biotech, pharmaceutical, and medical device industries. Our partners trust Coastline International to manufacture and deliver surgical devices, Class I and Class II devices, aesthetic products, medical electronics, and more.
Learn More About Medical Device Manufacturing in Mexico
Are you looking to reduce your manufacturing costs without sacrificing quality or customer service? If you’d like to learn more about how to start manufacturing your company’s medical devices in Mexico, contact Coastline International today at 888-748-7177 to speak with one of our representatives.