Medical Device Qualified Supplier Directory
West Contract Manufacturing Company Profile
Qualifications: ISO 13485, ISO 9001, FDA Registered, CGMP Certified, Exhibitor in at least 2 MD&M and/or MEDTEC shows
Markets Supplied: North America
West’s Contract Manufacturing group is a process driven, global, contract manufacturer of pharmaceutical and medical devices. With seven locations throughout North America and Europe, the West Contract Manufacturing team is focused on serving the needs of healthcare companies by providing a single sourced solution from product conceptualization through manufacturing and final packaging. Capabilities include: concept design, engineering development, prototyping, production scale up, validation and full scale manufacturing. All of our Contract Manufacturing healthcare facilities are ISO 13485 certified, and cGMP compliant.
With project start-up costs and limited resources you need a partner that has a demonstrated track record of success and can support high-volume, complex device contract manufacturing.
- Full-service molding and assembly solutions
- Primary and secondary packaging
- Real-time process monitoring and lean manufacturing principles
- ISO Class 7 and clean room assembly operations (at key facilities)
At West our engineers take an innovative yet scientific approach to the development of your products.
- Collaborative cross functional engineering teams
- Rapid component development
- Optimized process for manufacturing efficiencies
- Design for manufacturability (DFM)
It’s essential to partner with an organization that has established, maintains and applies a compliant quality management system throughout the product life cycle.
- Comprehensive risk management system
- Experienced personnel dedicated to regulatory compliance
- Registered with FDA as a drug repackager/re-labeler(key facilities)
- Seamlessly integrated within manufacturing with independent oversights
- Key Process Indicators (KPI) driven and monitored by plant and by business units
- Validated documented management systems
At West, we are here to help you develop and commercialize your medical device, drug delivery systems and combination products. Each year, our Contract Manufacturing facilities supply billions of components and devices to our pharmaceutical and medical technology customers. Because the products we manufacture are critical to saving lives around the world, we understand the need for a capable manufacturing process and Quality Management System that delivers the highest quality components and devices to our customers.
Specific to drug delivery devices our facilities are ISO 9001 and/or ISO 13485 certified and cGMP compliant. West is a Class II and Class III medical devices contract manufacturer. Select sites are FDA registered drug re-packager/re-labeler and all sites adhere to a Lean Sigma Culture. Our device assembly expertise offers a fully scalable solution from support of clinical trials using manual processes through high-volume commercial applications requiring fully integrated, high-speed automation.
Devices in development or manufactured by West’s Contract Manufacturing facilities Include…
- Safety syringes and components
- Auto injectors
- Pen injectors
- Pulmonary delivery devices
- Oral dispensing devices
- Dry powder inhalers
- Ambulatory systems
West’s Contract Manufacturing facilities have a unique set of capabilities that align with the demanding needs of the Diagnostic Industry. These needs not only include every component we make but every system we integrate…ready for final distribution.
- Immuno-assay kits, molecular diagnostics kits, point of care consumables
- Robotic integration for inline assembly and packaging
- Foil applications with both in-line printing and pressure decay
- Label identification and reconciliation
- Reagent handling and integration
West Contract Manufacturing facilities have supported the world’s leading Healthcare companies by molding, manufacturing and supplying critical components and devices around the globe.
We offer an array of value-added solutions including; two shot molding, insert molding, optical molding, LSR molding, mechanical assembly, printing, laser etching welding, UV bonding and annealing.
Products manufactured or in development by West Contract Manufacturing facilities include:
- IV, Lab and blood filters
- Ophthalmic consumables and assemblies
- Surgical devices and disposables
- Integrated container systems
We realize that time-to-market is critical. With over 40 years of experience, we are skilled in managing complex, high-volume OTC consumer applications. Processes including the incorporation of lean principles are utilized to meet time-to-market expectations.
Products Manufactured by West include:
- OTC healthcare products
- Caps and closures for the food & beverage industry
- High volume consumables
- Integrated container systems – bottles & closures
By The Numbers…
- Seven manufacturing sites throughout North America and Europe
- Over 300 injection molding machines
- Over 60 semi-automated and automated assembly cells in operation
- over 100 certified black belts and green belts
- 95% of injection molding machines tied to advanced process monitoring systems
- Low, single digit employee turnover
- Division of West with stable management structure
- Manufacturing excellence is our cornerstone
- Six sigma / data driven approach to continuous improvement
- Narrow Market focus – Healthcare and select Consumer Products
- Common systems – ERP, Doc. Control, Root Cause Analysis
For more information contact West Contract Manufacturing