Laser Repair Service
Are you aware that most laser repair service technicians don't actually know what they're doing? Sure, they know how to clean optics. Sure, they may know the basic rules for optical alignment. Sure, they may know how to check individual components. And, sure, they know how to replace parts. However, laser repair is expressly governed by 21 CFR 1040.10-11. Any and all laser repair service performed on a medical laser or light emitting device needs to be performed in accordance with manufacturer specifications. Though not all of the manufacturer specifications always exceed local, state, and Federal guidelines, some do. This may mean your tech is calibrating your laser to arbitrary numbers- ie. 20% by ANSI standards, vs. 10% tolerance by manufacturer standards. Some manufacturers set their standards as tight as 5% for output power measurements. This may also mean your tech lacks specific laser repair service software, special tools, or instructions only found in the service information provided by the manufacturer.
Laser Repair Facts
The problem is most third party laser repair and service companies have no idea how to legally acquire service information directly from manufacturers. CRC Biomedical does! We are the industry leaders and innovators of a process we call "21 CFR Requests." Through this process, we have acquired service information from secretive companies like Sciton, Cutera, Candela, Cynosure, Iridex, AMS, Spectranetics, and others! We are the only service company that adheres to FDA requirements, is completely open to FDA oversight, AND is staffed by Certified Biomedical Equipment Technicians with certifications as Certified Laser Repair Technicians! We have broken the illegal monopolization of the laser repair and service industry by laser manufacturers, and this means you don’t have to rely on manufacturers for laser repair service, service contracts, and their exorbitant costs.Laser Repair Safety
Because our techs have a background in Biomedical Electronics, we look for things most others don't. We keep patient safety as our number one priority; most laser repair service techs don't even consider your clients as "patients." We assist our customers in FDA reporting of adverse events. We assist our customers in equipment procurement, and ensure the proper 510k or Pre-market Approval paperwork has been filed, reviewed, and accepted by the FDA. We will not advise you to purchase equipment that is not FDA approved, nor will we allow our customers to use equipment serviced outside of FDA regulations. We will do everything within our power to ensure that your service offerings are in accordance with local, state, and federal laws, and that the equipment you are using is cleared for the procedures they are marketed for. We will never sell you a laser we cannot service, nor will we recommend a device we cannot acquire replacement parts and accessories for. If you become a member of our mailing list, you will receive periodic notices regarding FDA warning letters, FDA recalls, adverse events listed in the FDA’s MAUDE database, and time to time we will send you coupons you will be able to use on your next laser repair or periodic maintenance.If you want to work with a company that will save you time and money by doing things right the first time, improves efficiency and delivery of service, ensures patient safety and regulatory compliance- a company that cares for YOU AND YOUR PATIENTS, contact CRC Biomedical Services! We are your laser repair specialists.
Mickey A. Couvertier, CBET, CLRT
President/Senior Technician
202-679-8357
laser laser repair
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