Medical Device Qualified Supplier Directory
West Contract Manufacturing/Tech Group North America Inc. Company Profile
Qualifications: ISO 9001, ISO 13485, 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)
Design and Development Solutions
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)
Quality Control & Regulatory Expertise
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
The Markets We Serve
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.
Pharmaceutical (Pulmonary & Injectable)
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
Diagnostics (Molecular and Point of Care)
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