30 Years of Manufacturing
Coastline has manufactured medical devices for OEM clients for over 30 years. We know what it takes to meet the demanding quality standards associated with 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.
ISO Class 8 Clean Rooms
We operate several Class 8 (Class 100,000) clean rooms within our FDA registered medical device manufacturing facilities.
Import-Export Services
OEM clients rely on Coastline's import-export expertise to ship finished medical device products to the US and most global destinations.
Capabilities
- manual assembly of components and subassemblies
- secondary manufacturing processes
- ultrasonic welding
- laser beam welding (outsourced)
- gluing and solvent bonding
- packaging and bagging - finished product
- packaging - pre-sterilization
- private labeling - printing and application
- sterilization (outsourced)
- medical textiles; soft goods sewing
Procurement and Logistics
- procurement-materials/components
- materials management
- tracking and lot traceability
- import/export management
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.
Qualification Services
- quality assurance testing
- part measurement
- first article inspection
- production qualifications
- process qualifications
- fixture qualifications
- multi-run validations
Major Product Categories
- Disposables and consumables
- Sterile and non-sterile
- Medical electronics
Testimonial
