About Fathom Engineering

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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Website
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Employees
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Industry
Medical Equipment Manufacturing
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Headquarter
600 Addison St, Berkeley, California 94710, US
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Founded
0
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Keywords
Accident Reconstruction, Design, Medical Device Product Development, Failure Analysis, Engineering Consulting, Nitinol

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