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Laser Product Regulatory & Safety Compliance
US manufacturers of lasers or products which incorporate lasers must comply with the US federal requirements of the United States regulation, 21 CFR, section I, subchapter J, sections 1000 to 1040.11. Most laser products must be registered and certified prior to the introduction of the product into commerce. "Introduction into commerce" includes offering the product for sale or even public demonstration such as a trade show.
Also, to be compliant with the requirements of 21 CFR most laser products must employ certain engineering features, labels, include specific user information, and an initial product report must have been filed prior with the US government.
US laser product compliance is enforced by "The Center for Devices and Radiological Health" (CDRH) a division of the US Food and Drug Administration (FDA). Failure to comply with the product requirements can result in expensive "Corrective Actions" (a product recall) and/or fines up to $300,000.
European manufacturers, and products sold in the European Union must comply with the requirements of IEC 60825-1 safety standard.
Stack Technical Services provides complete regulatory consulting to ensure your laser products fully comply with US and/or European laws. We will handle your compliance project from beginning to end you can concentrate on getting your product to market. Call us today to discuss your product! If you want to get started exploring the regulations yourself follow the link below.
On line information for US Laser Product Compliance: Click Here!
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Laser & Electro-Optic Product Design and Engineering
Need to speed up your product development?
Our team has more than 20 years experience in developing laser and electro-optic products for commercial, medical and display applications. We have probably already faced and solved a design issue that you'll spend countless hours resolving. Don't reinvent that wheel! Every year we save engineering departments thousands of dollars, and more importantly, weeks of lost time by handing them off-the-shelf, or slightly modified instant solutions.
But where necessary, we'll design from the ground up too! We can provide design engineering and prototypes for a sub assembly or your entire product. We also regularly source unusual lasers and non-laser light sources for new products.
Our design teams handle all disciplines under one roof
· Optical Design
· Mechanical and Packaging
· Electronic Development
Prototype & Production Manufacturing
Our state of the art clean rooms and electro-optic manufacturing facility allow us to quickly build one prototype or hundreds of production units. We will happily turn-key your entire product from concept to packaging and shipping.
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