Welcome to Compliance Consultants...

...the more you learn...the more you will want us for FDA!

Our typical client The following defines an average project accomplished for an inventor from a foreign county who has a small engineering group (under 10 engineers in the technology). The device would be new and the first of this kind for the inventing company. This device may have few predicates in the U.S. This device may contain a computer program or computer software that either measures or treats patients as a Class II device. This device may include a calibrated input/output unit or a sterile disposable. Engineering documents may exist but the company would require a complete system to meet ISO-9000.

Our typical customers will incur higher scrutiny from FDA since the devices are usually "never been built before" systems or devices. This usually translates to the FDA will exercise higher approval discretion since the FDA would have fewer enforcement powers.

At Compliance Consultants, we understand the special problems in getting acceptance at the FDA for "off shore products" and overcoming the "not invented here" bias which exists in the U.S. We will work both at our offices and with you in you country. Rely on us to be your long-term partner to achieve marketing success. Please contact us to continue this dialog.

copyright by Compliance Consultants, Stamford, CT USA, September 2001