Medical Certification Implications
Laser Compliance's work normally covers only the laser product compliance aspects (e.g., CDRH and IEC), and any related import/export licenses and permissions, of this product and project. Unless otherwise noted in writing, the customer is fully responsible for all medical and safety related implications, claims, indications and certification(s) such as 510K and related issues.
Guarantee of Outcome
Laser Compliance works in good faith to assist customers in obtaining certification and resolving non-compliant situations. However, we cannot guarantee or otherwise assure that any given customer, project or product can or will be granted the desired certification or disposition, or so granted in any specific timeframe. Payment as per the agreed-upon contract is due for all work performed, regardless of intermediate or ultimate product or certification disposition.
Liability Implications
Laser Compliance assists the customer in navigating and preparing documents pertaining to laser product classification, certification, registration, or assisting in corrective or recall actions. This assistance in no way implies any suitability or approval by Laser Compliance® of any specific device as safe or efficacious for any product or use. Laser Compliance® will not be held liable in any case now or in the future from any situation or incident arising out of the use or inability to use any product or device. Customer, its associates and affiliates shall hold Laser Compliance®, its consultants and personnel harmless in all cases arising out of any matter involving any product, device, advice or consulting. Customer agrees that it undertakes this work fully at its own risk. Furthermore, that it has been advised on all facts and takes all actions with full intent and acting on its own behalf.
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