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

Meredith Schwarz

Meredith Schwarz

Design & User Experience Researcher

Denice Medeiros

Denice Medeiros

R&D Buyer

Amelia Gudex

Amelia Gudex

Associate Design Assurance Engineer

Joseph Kralicky

Joseph Kralicky

Principal Software Engineer

Thomas Ruth

Thomas Ruth

Mechanical Engineering Manager

Joe Gordon

Joe Gordon

Director of Innovation