Validation & Launch
Every product must ultimately demonstrate three things, the product developed is fit for its intended use, is safe to use and the manufacturing process in place is capable of consistently delivering a quality product.
Launch-ready medical devices
Validation is complete when established objective evidence confirms that device specifications conform with user needs and intended use(s). A critical component to validation is proving quality, safety and efficacy are designed into the product.
Ximedica employs the following validation methods:Simulated use
- Clinical use
- Ergonomic evaluation
Fully integrated disciplines support product realization
Starting with design validation builds and testing through to the coordination of all required production activities from manufacturing and quality procedures to the proper structuring of BOM’s and Routers and IQ/OQ/PQ efforts draws heavily upon a variety of resources.
Validation & launch outcomes
- Process validation master plan
- Process FMEA
- Installation qualification
- Operation qualification builds
- Performance qualification builds