Ximedica

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
  • Bioskills
  • 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

 

Wherever you are in your process, Ximedica can help.

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At Ximedica, our people define who we are.

More About Our People

Bernie Oliveira

Bernie Oliveira

Production Team Leader

Odie Maknoxa

Odie Maknoxa

Senior Manufacturing Engineer

Jennet Toyjaynova

Jennet Toyjaynova

Research & Development Engineer

Chelsae O'Halloran

Chelsae O'Halloran

Senior Design Assurance Engineer

Kelly West

Kelly West

Director of Quality

John Bergman

John Bergman

Senior Mechanical Engineer