Experienced. Qualified. Responsive.
The medical device industry demands high quality and timely delivery. Our device assembly 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).
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.
Coastline operator assembling an infant feeding tube set
Capabilities
- Manual assembly of components & subassemblies
- Finished device assembly
- Secondary manufacturing processes
- Mechanical assembly
- Solvent bonding
- UV curing
- Ultrasonic welding
- 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
Procurement and Logistics
- Complete turn-key solutions
- 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.
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
Assembly production in one of Coastline's ISO Class 8 cleanrooms
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