Ximedica

Design & Development

During these phases, design concepts are translated into fully engineered design solutions that are rigorously tested to confirm final design. This transition to detailed engineering draws heavily on the multi-disciplinary makeup of our program teams and agile development process.

Minimizing risk in the design effort is required by ISO 14971 & adopted practice at Ximedica

Core to the design development effort, user needs are translated into measurable, finite specifications that result in a product that is safe and efficacious. A risk evaluation and mitigation strategy applied early and throughout product development provides assurances that the design effort will minimize design, process and use-errors.

Robust test methods reaffirm design decisions

During verification a product undergoes rigorous testing to verify that function, reliability, usability, and safety meet specifications. Core to this activity are statistical techniques to determine proper sample sizes based on risk and measurement system analysis. Utilizing these techniques along with independent reviewers ensures test methods are robust and validated.

Design & development outcomes

  • SDS, Risk Management, UFMEA
  • DFMEA
  • Tooling purchase & debug
  • Pilot build
  • Traceability matrix
  • Final Master verification plan

FROM DEVELOPMENT TO LAUNCH

 

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

Dan Carlson

Dan Carlson

Software & Electrical Engineering Manager

Rory Kirby

Rory Kirby

Talent Acquisition Specialist

Michelle Wu

Michelle Wu

VP, Quality

Talia Serrecchia

Talia Serrecchia

Clinical and Human Research Affairs Specialist

Donna Torres

Donna Torres

Program Manager

Rick Beaulieu

Rick Beaulieu

VP, Product Development