Verification and Implementation
Our Design Verification and Implementation capabilities help our customers seamlessly navigate the transition from development into production.
We help our customers and manufacturing partners anticipate and address risks before they can impact the schedule. Our implementation team jumps into new product development early, leading design verification planning, creating capable test methods, supplying technical verification expertise, manufacturing planning and qualification, supplier sourcing, and the supply chain management to effectively get your product over the finish line and into production. We want to ensure that our clients realize ROI in their development investments by efficiently getting products to the market.
We actively manage the development to launch process to develop and test prototypes for performance verification and higher volume prototype production runs for market acceptance testing and process verification. Because we are an ISO 13485 quality-certified firm, we understand the unique regulatory and market pressures involved in bringing a new drug delivery, diagnostic, lab, surgical system or device to market. We routinely coordinate clinical trial manufacturing builds typically required for medical products. From prototype, through verification testing to production product launch, our pre-production prototype manufacturing and assembly capabilities are geared to provide efficiency while managing risk.
• Design and Process Verification planning and Testing
• Prototyping, pilot, and high volume prototype production builds
• Global manufacturing sourcing, qualification, and supply chain management
Verification and Implementation Capabilities
• Design verification and testing
• Prototyping fabrication and high volume prototype production builds
• Manufacturing and Production planning
• Quality engineering and management
• Process Validation, IQ/OQ/PQ
• Parts inspection and qualification
• Clean room assembly and testing
• FDA GMP compliance
• Supply chain development and management
• Global sourcing and supply chain management
|
