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, so we are here to help with our laser certification and compliance services.
Our Laser Compliance Services
To ensure that your product has smooth sailing, our laser compliance services cover the following areas:
Design and engineering assistance
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Laser Classification strategy options.
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Determination of product modification requirements to meet performance requirements (if any).
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Assistance in solving engineering problems, finding laser component suppliers, etc.
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Laser Classification, Laser Product Certification Assistace & Testing
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Generation of certification test program and checklist.
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Assistance in securing appropriate test equipment for laser product certification services.
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Training on use of test equipment where necessary.
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Meeting government regulatory requirements
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Product certification for simultaneous compliance with US and EU regulations.
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Creation of Initial Product Report for product certification.
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User manual requirements, preparation assistance and review.
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Assistance in determination and acquisition/modification of labeling.
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Education on Annual Report and manufacturer record-keeping requirements.
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Import and export licenses and other requirements.
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Import and export requirements
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Provide method of handling OEM and export models.
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Education on distributor record-keeping requirements.
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Solving problems and avoiding penalties
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Guidance prior to government inspections.
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Development of a Corrective Action program if required by regulators.
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Assistance in any recalls, repairs, replacements or refunds, if required by the Corrective Action program.
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Future CDRH compliance issue support.
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All work performed is done under our standard terms and conditions

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