A Trusted Contract Manufacturing Partner Since 1982

Medical Device Manufacturing in Mexico

Experienced • Qualified • Responsive.

 

Coastline provides medical device manufacturing in Mexico. Medical device manufacturing and assembly demands high quality and timely delivery. Our medical manufacturing experience, qualifications, and responsiveness helps our clients consistently meet those demands.

Medical Device Manufacturing in Mexico: 40 Years of Excellence

Coastline has manufactured products for medical device and life science OEM clients for four decades. We know what it takes to meet the increasingly demanding quality standards associated with assembly and packaging in the medical device, biotech, life science, and pharmaceutical industries.

Medical Device Manufacturing: Consistent Quality at Lower Cost

OEM clients typically find the cost of our medical device manufacturing services to be 30% or more below other contractors or the client's own in-house costs. Our clients also know we are fiercely committed to meeting their expectations for product quality, delivery, and service. Since Coastline is a nearshore manufacturer, OEM clients may also benefit from lower transportation costs and reduced transit time.

workers in sterile garb lab manufacturing medical devices

Coastline cleanroom production

ISO Class 8 Clean Rooms in the Medical Device Industry

We operate several Class 8 (Class 100,000) clean rooms within our FDA registered medical device manufacturing facilities. Of the total 50,000 square feet of manufacturing space, Coastline has expanded to over 9,000 square feet of cleanroom space. All medical production is completed in ISO 13485 standards (ISO 13485:2016).

Medical Device Procurement - Logistics & Import-Export Services

  • Materials management, warehousing
  • Tracking and lot traceability
  • Can provide end-to-end turnkey solution
  • Procurement: components & supplier sourcing
  • Mexico-USA importation/exportation services
  • Coastline manages the Customs processing, with ability to release goods landed in the US
  • OEM clients rely on Coastline's import-export expertise to also ship finished medical devices to the US and global destinations

Coastline minimizes customer investment of time and resources by handling all logistics for transporting (importing as appropriate) all raw materials and components for medical devices to its manufacturing facility in Tijuana Mexico.

Capabilities of Medical Device Manufacturing Operations

  • Manual assembly of components & subassemblies
  • Finished device assembly
    worker in sterile garb sitting at table with overhead light, assembling a medical device

    Coastline operator performing adhesive bonding

  • Secondary manufacturing processes
  • Mechanical assembly
  • Solvent bonding
  • UV curing
  • Ultrasonic welding
  • RF welding (Radio Frequency)
  • Friction fit assembly
  • Thermoforming
  • Clicker press die cutting
  • Hot stamping
  • Adhesive processes; gluing and bonding
  • Packaging and bagging - finished product
  • Kitting - surgical kits, thermoform trays, lidstock
  • Packaging - pre-sterilization
  • Private labeling - printing and application
  • ETO & E-beam sterilization (outsourced)
  • Medical textiles; soft goods sewing
  • Re-work
  • Tooling & Fixture development
  • Lean Manufacturing principles
  • Program Management

Major Product Categories for Medical Device Manufacturing in Mexico

worker in sterile garb assembling IV lines

Coastline cleanroom tube set assembly

  • Disposables and consumables
  • Infusion therapy
  • Surgical devices
  • Ophthalmic devices & assemblies
  • Class I & Class II devices
  • Sterile and non-sterile
  • Medical - aesthetics products
  • Medical electronics
  • Biotechnology
  • Pharmaceutical

Examples of Medical Devices Include:

  • Various tube set assembly
  • IV administration & extension sets, enteral feeding sets
  • Blood collection devices, blood management
  • Catheter set assembly & packaging
  • Ophthalmology devices
  • Laparoscopic surgical devices
  • Specialty suture devices
  • Surgical kits
  • Diagnostic test kits
  • Surgical hoods & gowns
  • Wound treatment (including vacuum drains)
  • Custom liners, pads, straps
  • Specialty products for medical & aesthetics industries
workers in sterile garb sitting at long tables assembing medical equipment

Assembly production in one of Coastline's ISO Class 8 cleanrooms

Qualification Services for Manufacturing Medical Devices

  • Full transfer of production lines
  • Program Management
  • Quality assurance testing
  • Part measurement
  • First article inspection
  • Production qualifications
  • Process qualifications
  • Fixture qualifications
  • Multi-run validations
  • Sterilization management
  • PFMEA
  • IQ - OQ - PQ

Advantages of Mexico as a Medical Device Manufacturing Hub

Mexico's medical device industry has grown significantly in recent years, making it a premier destination for medical device companies seeking to optimize their production processes. The strategic location, skilled workforce, and favorable business environment have established Mexico's medical device manufacturing as an ideal choice for companies in the medical device market.

Strategic Geographic Location

Mexico's medical device industry provides significant logistical advantages for medical device manufacturers. This strategic positioning enables:

  • Same-day or next-day delivery of medical devices to major US markets
  • Reduced shipping costs compared to other international manufacturing industry locations
  • Similar time zones facilitating real-time communication for medical device production
  • Easier site visits and quality inspections of medical devices by US-based management
  • Faster response to medical device market demands and supply chain disruptions

Skilled and Cost-Effective Workforce

Medical device manufacturing companies in Mexico benefit from a highly skilled workforce specifically trained in producing medical devices:

  • Extensive technical education programs focused on the manufacturing industry
  • Experience with precision assembly of medical devices and quality control processes
  • Lower labor costs than the US while maintaining high-quality medical devices
  • Strong work ethic and dedication to precision in the medical device manufacturing industry
  • Bilingual management teams facilitate smooth communication for medical device companies

Regulatory Compliance and Quality Assurance

At Coastline, regulatory compliance is paramount to our Mexico's medical device manufacturing operations. Our facilities and processes are designed to meet and exceed international standards for medical devices:

Comprehensive Regulatory Framework

  • FDA-registered facilities with full compliance monitoring for medical devices
  • ISO 13485:2016 certified quality management systems
  • Adherence to Good Manufacturing Practices (GMP) for medical and pharmaceutical sectors
  • Regular internal and third-party audits
  • Intellectual property protection for all client designs and processes

Quality Assurance Throughout the Process

Our commitment to quality extends throughout the entire manufacturing operations for medical devices:

  • Incoming materials inspection and verification
  • In-process quality checks at critical control points
  • Final medical products inspection and testing
  • Comprehensive batch record documentation
  • Continuous improvement initiatives promoting health technology excellence

Industry Leadership and Partnerships

  • Mexico's medical device industry continues to grow through strategic partnerships with top medical device companies worldwide. Coastline's position within this ecosystem offers significant advantages:
  • Established supplier networks specialized in components for medical devices
  • Collaboration with research institutions advancing medical device industry Mexico capabilities
  • Integration with global supply chains for medical equipment distribution
  • Knowledge sharing with other medical device manufacturing companies to establish best practices
  • Participation in industry forums focused on medical device innovation

 

Frequently Asked Questions On the Medical Device Manufacturing Industry in Mexico

What is medical device contract manufacturing?

Contract manufacturing in the medical device industry is very common, in which OEMs (original equipment manufacturers) work with contract manufacturing organizations, often referred to as CMOs or third-party manufacturers, to manufacture their product.  The contract manufacturers are required to manufacture the product to the original specifications and meet all quality requirements, effectively having no difference than being produced by the original manufacturer.

There is a vast array of products used in the medical device industry (diagnostics, surgical, treatment, therapeutic, monitoring, aesthetics, and more) of which have immensely high usage volume.  These products and devices require sufficient manufacturing resources to support the demand and as such medical contract manufacturing has become a viable solution to provide such scalable solution.  This often includes international sites and strategic partners to provide support in design, manufacturing, and transportation/logistics to healthcare locations throughout the world. 

What are the major steps in manufacturing medical devices?

The pathway from product concept to scalable manufacturing status can be quite daunting.  While having a great idea for a medical solution is fantastic, it requires some major steps to get from idea to manufactured finished good. The major steps in manufacturing medical devices are: 

  • Initial concept
  • Product design
  • Prototyping
  • Regulatory Requirements (if applicable)
  • Device testing
  • Design verification and validation
  • Product manufacturing
  • Sterilization (if applicable)

How is Coastline’s nearshore medical device manufacturing better than offshore?

Outsourcing your medical device manufacturing needs is a great step when it comes to increasing efficiency, reducing costs, and increasing overall production capacity. However, choosing where in the global medical device market to outsource plays a significant role in the outcome. 

Nearshore medical device manufacturing in Mexico can offer you easy access to the facility, quick shipments of finished products, and a highly trained, quality manufacturing team, while also achieving the cost reduction and increased capacity to scale.

What are the benefits of using Coastline for my medical device manufacturing in Mexico?

Coastline International has been providing medical device manufacturing support to leading global OEMs for many years.  Established in 1982, Coastline has been in the medical device manufacturing industry in Mexico for over 40 years and has developed a well-established team and facilities to provide manufacturing solutions across many applications.  We have all witnessed how strained the healthcare system in the U.S. can get during a crisis. If you have a medical device or a piece of medical equipment that needs to be manufactured, you need to have the confidence that it can be handled by an experienced, qualified facility with a thoroughly trained team. You want your finished product to arrive where it is needed when it is needed. 

At Coastline, we meet your demands - without sacrificing quality - to provide you with finished products that meet all necessary standards. The entire process saves your company both time and resources. 

How can I learn more?

If you are ready to learn more about Coastline International and how it can meet your medical manufacturing needs, call us at (888) 748-7177.

Testimonial

"Coastline has been a manufacturing partner for many years, supporting the growth of our business and increased volume in production as our product demand has scaled.  Coastline is committed to Quality, and consistently reliable.  The team is always available and we appreciate the ability to visit the site conveniently as needed.  Transferring production to Coastline has provided a cost-reduction solution while also providing increased capacity."
 —President, US-based Medical Device OEM