New Product Introduction and Risk Management

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 FDAcompliant Quality Management System.

New Product Introduction — Risk Management

During the formal New Product Introduction (NPI) process, all aspects of the product launch are reviewed including drawings, BOM, schematics, assembly documentation, quality requirements, regulatory requirements, packaging and labeling, fixtures, testing requirements and more.

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.