CDRH DOCUMENT PREPARATION

Our Laser Safety Officers have Engineering Backgrounds and assisting Original Equipment Manufacturers (OEM’s) is our specialty.

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OEM SUPPORT

We have extensive experience working with OEMs

If you are an OEM integrating a Class IV laser into your equipment, or if you are an End User Customer integrating a laser into an existing system, we will prepare the proper documentation required to file with the Center for Devices and Radiological Health (CDRH). We will review the beam shield enclosure design, determine Nominal Hazard Zones (NHZ), calculate Maximum Permissible Exposure (MPE), determine Nominal Ocular Hazard Zones (NOHD) and make the necessary recommendations to comply with the Federal Laser Product Performance Standards (FLPPS). Our company will then prepare the FDA Form 3632 and assist in delivering proper documentation for the CDRH. Once the proper forms have been filed, you will receive an accession number approving your application for sale/use.

EXPERIENCE YOU CAN COUNT ON

Laser Safety Compliance LLC brings years of laser industry experience to your company to make a difference