irc-us.com irc-us.com

irc-us.com

IRC - Your Partner in FDA Compliance

IRC assists with process of quality management, testing and preparing documentation to submit to FDA for clearing a Medical device to sell the US.

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IRC - Your Partner in FDA Compliance | irc-us.com Reviews
<META>
DESCRIPTION
IRC assists with process of quality management, testing and preparing documentation to submit to FDA for clearing a Medical device to sell the US.
<META>
KEYWORDS
1 about us
2 services
3 what we do
4 post market issues
5 us agent services
6 technical affairs
7 regulatory assistance
8 irc us
9 email charliemack@irc us com
10 irc china
CONTENT
Page content here
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PAGE
about us,services,what we do,post market issues,us agent services,technical affairs,regulatory assistance,irc us,email charliemack@irc us com,irc china,email ircchina@irc us com
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IRC - Your Partner in FDA Compliance | irc-us.com Reviews

https://irc-us.com

IRC assists with process of quality management, testing and preparing documentation to submit to FDA for clearing a Medical device to sell the US.

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irc-us.com irc-us.com
1

IRC

http://irc-us.com/support.php

FDA 510(k) Document Creation and Submissions. Testing and Validation Assistance. Medical Device Concept Assistance. Quality Systems Audits and Set up. FDA How to Market your device. FDA Registration Databases For Medical Devices. Tel: 86-21-64829545, 64803667. Parker, Arizona 85344.

2

IRC

http://irc-us.com/services.php

FDA 510(k) Document Creation and Submissions. Testing and Validation Assistance. Medical Device Concept Assistance. Quality Systems Audits and Set up. IRC's FDA Medical Device Compliance Service:. FDA Importer/Initial Distributor Registration. FDA Medical Device Listing (MDL). FDA US Agent Registraion. FDA GMP Establishment Inspection Support. FDA GMP: QSR820 Compliance Servcie.

3

IRC

http://irc-us.com/index.php

FDA 510(k) Document Creation and Submissions. Testing and Validation Assistance. Medical Device Concept Assistance. Quality Systems Audits and Set up. We are here to assist you with your Medical Device needs. We serve the Medical device community to assist them with the rigorous process of quality management, testing and preparing the documentation to submit to the FDA for clearing a Medical device to sell in the US market. We will assist you with your regulatory needs,. A Premarket Notification [510(k)]...

4

IRC

http://irc-us.com/about.php

FDA 510(k) Document Creation and Submissions. Testing and Validation Assistance. Medical Device Concept Assistance. Quality Systems Audits and Set up. IRC was founded in 2004 by Charlie Mack and Elvis Ge. Has worked for Minolta as a QA Manager,Draeger as a Management Representative, UL as a Senior Account Manager and IRC as the Operations Manager. Pursuit of a statutory amendment for FDA to consider off-label use when determining the intended use of a device. Establishment of a Class IIb that would requi...

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IRC - Your Partner in FDA Compliance

We are here to assist you with your Medical Device needs. IRC serves the Medical device community to assist with the rigorous process of quality management, testing and preparing the documentation to submit to the FDA for clearing a Medical device to sell in the US market. IRC’s expert engineering staff and partner testing labs have the experience and knowledge to guide you through the entire process. We offer professional services in Shanghai, China and the United States. Your Partner in FDA Compliance.

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