Fathom Engineering

Medical Equipment ManufacturingCalifornia, United States2-10 Employees

Combined, our technical consulting team leverages over a century of successful product commercialization experience to support our client’s rapid navigation through the challenging development, clinical trial, regulatory submission, and post market evaluation stages in this dynamic and competitive global medical device market.

Whether using Fathom Engineering as a complete turnkey product development partner, or as a supplement to your existing team, we support your complex 510(k) and PMA development activities including:

design optimization for:
        safety
        efficacy
        manufacturability
        differentiability
        cost 
   
 failure analysis
 project management
 material selection
 specification and protocol creation
 verification and validation activities
 supplier qualification
 manufacturing scale-up
 quality systems design 

Our network of affiliate testing laboratories can be utilized to test iterative designs for functionality, or frozen designs for demonstration of acceptable performance, biocompatibility, and safety in support of your regulatory submission and/or litigation.

Fathom's engineers have consulted for most of the major medical device companies in the United States including:

    Medtronic, Inc.
    Zimmer, Inc.
    Oral-B (Procter & Gamble)
    Cordis Corporation
    ICU Medical, Inc.
    Cook Medical
    Covidien
    Abbott Laboratories
    W. L. Gore & Associates, Inc. 
    Alcon
    Stryker
    Boston Scientific
    Terumo
    Ormco
    Dentsply International, Inc.
    3M
    Edwards Lifesciences Corporation
    St. Jude Medical, Inc.

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