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.

35 Years of Manufacturing

Coastline has manufactured products for medical device and biotechnology OEM clients for over three 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.

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.

ISO Class 8 Clean Rooms

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).

• 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 device products 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

• Manual assembly of components & subassemblies
• Finished device assembly
  

  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

• 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 products 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

Qualification Services

• 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