Experienced. Qualified. Responsive.
The medical device industry demands high quality and timely delivery. Our experience, qualifications, and responsiveness helps our client consistently meet those demands.
35 Years of Manufacturing
Coastline has manufactured medical devices for OEM clients for over three decades. We know what it takes to meet the increasingly demanding quality standards associated with manufacturing in the medical device, biotech, 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
- Secondary manufacturing processes
- Medical finished devices
- Mechanical assembly
- Solvent bonding
- UV curing
- Ultrasonic welding
- Friction fit assembly
- 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
- Class I & Class II devices
- Sterile and non-sterile
- Medical - aesthetics products
- Medical electronics
- Biotechnology
- Pharmaceutical
Examples of products include:
- Various tube set assemblies
- IV administration & extension sets, enteral feeding sets
- Blood collection devices, blood management
- Catheter set assembly & packaging
- Wound treatment (including vacuum drains)
- Laparoscopic surgical devices
- Specialty suture devices
- Surgical kits
- Diagnostic test kits
- Surgical hoods & gowns
- Custom liners, pads, straps
- Specialty products for medical & aesthetics industries
Assembly production in one of Coastline's ISO Class 8 cleanrooms
Qualification Services
- Program Management
- Quality assurance testing
- Part measurement
- First article inspection
- Production qualifications
- Process qualifications
- Fixture qualifications
- Multi-run validations
- Transfer of production lines
- IQ - OQ - PQ