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About Us

About Fang Consulting

Welcome to Fang Consulting. We specialize in Regulatory Affairs consulting, Quality System consulting, and device fulfillment for the medical device industry. We help you make sense out of Regulatory Affairs and Quality Systems, both domestically and internationally. Our consultants are well versed in regulations, certifications, and working with government agencies in the U.S. and abroad.  We also offer storage, distribution, and QMS solutions once your product has gone to market. Our staff of consultants brings real world experience to the table to help solve your problems in a way that makes sense for your business.   

While many of us in the US think immediately of the FDA when regulations are mentioned, our global marketplace demands global compliance with a wide range of agencies and ministries. From the initial IDE through PMA, or de novo pathway or just a 510(k), we can help take your concept through design and approval with a minimum of delays in your time to market. We are also happy to assist with your CE Marking and ROW registrations. 

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