To ensure that your product has smooth sailing, our services cover the
following areas:Design and engineering assistance
Classification strategy options
Determination of product modification requirements to meet
performance requirements (if any)
Assistance in solving engineering problems, finding laser
component suppliers, etc.
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
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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 happened at a Las Vegas
tradeshow. CDRH inspectors can appear at anytime, and certainly will one
day. Selling non-compliant products is a ticking time bomb. 
DESIGNING YOUR PRODUCT FOR COMPLIANCE
REGULATIONS AND REQUIREMENTS
PENALTIES FOR NON-COMPLIANCE