Cogmedix Services
- Medical Device Contract Manufacturing
- New Product Introduction (
NPI ) - Documentation Refinement
- Process Validation
- Storage & Fulfillment
- Refurbishment & Repair Depot
About Cogmedix
New Product Introduction — Medical Device Manufacturing
Cogmedix follows a well documented and ISO driven New Product Introduction process. This is the formal process of entering the product into our volume manufacturing environment and our ISO 13485:2003 certified and FDA compliant Quality Management System.
During the formal New Product Introduction (NPI) process, all aspects of the product launch are reviewed including drawings, BOM, schematics, wire run lists, assembly documentation, quality requirements, regulatory requirements, packaging and labeling, fixtures, testing requirements and more.
New Product Introduction — Risk Management
This is the phase where we establish the product’s Risk Management in accordance with ISO 14971:2007, Device Master Record and Device History Record requirements with our Quality Management System, as well as any special equipment or processes we will follow for test, assembly, and inspection.
The New Product Introduction Process
The NPI process is also used as an effective way to manage customer initiated changes such as new product features or changes to the manufacturing environment in a controlled and compliant manner.
Following a rigorous NPI process helps ensure that product requirements and our customer's needs are met, that we are compliant from the start, and that we produce high quality, reliable products - repeatedly.
Cogmedix – 70 Hartwell Street -– West Boylston, MA 01583
What can Cogmedix do for you?
Cogmedix provides contract review, NPI, supply chain management, rapid ECO processing, ensuring that process validation and documentation is complete on new or changed process due to ECN.
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Cogmedix – 70 Hartwell Street -– West Boylston, MA 01583
What can Cogmedix do for you?
