At Laser Compliance we go above and beyond your expectations
 

Laser Compliance provides service for Consumer Products, Medical Devices, police & Military, Scientific Instruments and Entertainment.

We Can Help with Laser Certification


Laser Compliance® provides assistance to companies seeking initial certification as well as those that have been found to need corrective action. We specialize in commercial, scientific, consumer and military laser products.


Our Goal


Our goal is to get you to your product release or laser demonstration with a product that is fully legal so that you are not breaking federal law and getting cited… or shut down, such as happens each year at tradeshows. CDRH inspectors can appear at anytime, and certainly will one day. Selling non-compliant products with an incorrect laser certification is a ticking time bomb.



Our Services


To ensure that your product has smooth sailing, our services cover the following areas:


Design and engineering assistance


Laser Classification strategy options.


Determination of product modification requirements to meet performance requirements (if any).


Assistance in solving engineering problems, finding laser component suppliers, etc.



Laser Classification and certification testing


Generation of certification test program and checklist.


Assistance in securing appropriate test equipment for certification testing.


Training on use of test equipment where necessary



Meeting government regulatory requirements


Product certification for simultaneous compliance with US and EU regulations.


Creation of Initial Product Report for product certification.


User manual requirements, preparation assistance and review.


Assistance in determination and acquisition/modification of labeling.


Education on Annual Report and manufacturer record-keeping requirements.


Import and export licenses and other requirements.



Import and export requirements


Provide method of handling OEM and export models.


Education on distributor record-keeping requirements.



Solving problems and avoiding penalties


Guidance prior to government inspections.


Development of a Corrective Action program if required by regulators.


Assistance in any recalls, repairs, replacements or refunds, if required by the Corrective Action program.


Future CDRH compliance issue support.




All work performed is done under our standard terms and conditions






Get a quote from Laser Compliance Today!
 
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