someone from my dr.'s office wherei was gonna do c3-r called me said they aint doin it for like 9 months for some reason..does anyone know anything about this and any place to do c3-r in mexico or usa??
they said their equipment is being pulled and some payment thing reevaluated...
c3-r
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GarethB
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Sounds like they are un happy about the equipment they purchased and want their money back.
Before any procedure can take place, it has to be qualified before the FDA will give the practice the OK to offer/carry out the procedure.
The qualification process is installation and documentation is completed to demonstrate it was installed correctly. Then there is operational qualification which is another document that needs completing to show that the instrument is working within its design peramaters. Performance qualification is the last to ensure that the instrment is perfoming as it was designed to and doing what the purchaser requested. As long as the perfomance qualification document details match what was requested by the purchaser and what was sold to them, getting money back is possible.
I kow where I work, to qualify equipment that is new to the company can take 6 to 12 months. Equipment that adds to cappacity still takes 3 months with the regulatory critera we need to achieve.
Before any procedure can take place, it has to be qualified before the FDA will give the practice the OK to offer/carry out the procedure.
The qualification process is installation and documentation is completed to demonstrate it was installed correctly. Then there is operational qualification which is another document that needs completing to show that the instrument is working within its design peramaters. Performance qualification is the last to ensure that the instrment is perfoming as it was designed to and doing what the purchaser requested. As long as the perfomance qualification document details match what was requested by the purchaser and what was sold to them, getting money back is possible.
I kow where I work, to qualify equipment that is new to the company can take 6 to 12 months. Equipment that adds to cappacity still takes 3 months with the regulatory critera we need to achieve.
Gareth
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Andrew MacLean
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c3-r
from the limited message i got on my phone from the dr's office, they are reevaluating the payment procedure for it and trying to get insurance companies to pay for it or something like that. and i don't even know anyone else that does it in the whole usa. ive heard of ppl having it done in mexico or europe. maybe someone can recommend a place outside of US somewhere and how much it costs?
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