Medical Device Directory

The Photonics Group

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7259 Leemel Drive
West Chester, OH 45069
Phone: click for phone
About The Photonics Group
  • If your product contains a laser, LED, or other Photonics technology, call us now.

    Since 1980 we have been offering the following services for Photonics-based medical products:

    - Proof-of-Concept and T&E prototype development;

    - Design review;

    - Compliance/risk engineering (to 21CFR1040.10/.11, IEC EN60825, and ANSI Z136);

    - Test (performance and compliance);

    - FDA filing and response

    Although preferable to get us started at conception, we will save you resources and get your product through compliance anytime during the product lifecycle.

    We are launching our "Start 2018 Campaign"- give us a call before the end of January and lock in a 5% discount against contracted services.
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Products by The Photonics Group
  • Consulting Services- FDA Submissions

    Since our start, we have established ourselves as SME (and recognized by the FDA) in 21CFR1040.10/.11. Not merely "filers", we assist in engineering and administration to make sure your filings go through smoothly and quickly. We offer standard compliance engineering and filing packages or can... Read More
  • Consulting Services- Product Safety Compliance

    Employing Photonics-based standards and regulations such as ANSI Z136, IEC/EN60825, and 21CFR1040.10/.11, we ensure your product is not only safe, but compliant as well. We offer standard compliance engineering and filing packages or can develop customized support services. All our work is... Read More
  • Consulting Services- Consulting and Training

    Few have the education and experience in Photonics to assist as broadly as The Photonics Group. We have trained thousands and through train-the-trainer programs, tens of thousands. Not merely forced upon employees, our training sessions are sought after because we mix technical information with... Read More