Regulatory Open Forum

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  • 1.  Electrical safety/EMC testing labs?

    This message was posted by a user wishing to remain anonymous
    Posted 02-Nov-2022 08:37
    This message was posted by a user wishing to remain anonymous

    My company is looking to run electrical safety and EMC compliance testing for a diagnostic device. We're looking for recommendations for outside testing labs to execute the testing and certification (for 510(k) and CE mark), with a preference for labs in the NE U.S. to make travel easier on our engineers. Any suggestions?


  • 2.  RE: Electrical safety/EMC testing labs?

    Posted 03-Nov-2022 01:02
    Please contact me directly (email best or text) as it depends on the type of device what would be best for your company.   There are several options but it also depends on additional needs best not discussed in a public forum.

    I will be available from Tues Nov 8 onward 8:30AM Pacific.

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    Leonard (Leo) Eisner, P.E.
    The "IEC 60601 Guy"
    Principal Consultant, Eisner Safety Consultants
    Mobile: (503) 709-8328
    Email: Leo@EisnerSafety.com
    Website: www.EisnerSafety.com
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  • 3.  RE: Electrical safety/EMC testing labs?

    Posted 03-Nov-2022 09:07
    Although we are not located in the NE U.S., Criterion, a Biotex, Inc. service can offer this testing for you out of our Houston, TX office. You can view our website here https://www.biotexmedical.com/criterion/ which also contains a link to our A2LA certificate of accreditation. We differentiate ourselves from the typical "test lab" because Biotex is a medical device design, development, and manufacturing company so we know the impacts of the assessment decisions we make and the feedback we provide on your product development process and manufacturing.

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    Wade Munsch
    Regulatory Affairs Manager
    Biotex, Inc.
    Houston TX
    United States
    Website: www.biotexmedical.com
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