Compliance Consultants have covered the globe with our regulatory 510(k)s in
every possible product category. Compliance Consultants has worked all over the
globe in a multitude of regulatory tasks in many foreign companies. Our projects
are what other FDA CDRH regulatory affairs consultants would want to put on
their resumes.
In Canada in 1988, we assisted in the product launch of one of the worlds' first computerized electrocardiograms.
In Canada in 1995, we designed, created, prototyped, and manufactured a disposable tubing set to support clinical trails.
In Australia in 1995, we assisted a new product launch in Cardio logical Software. In England 1997, we submitted the second in history -Humanitarian Device Exemption for a life saving catheter.
In Dortmund - Germany, 1998, we developed an application for the first non- invasive blood glucose meter.
In China & Taiwan 2003, we developed products for lasers and low level light therapy devices.
In Argentina, 2004, we helped develop an upgrade existing fluoroscopic system to add a digital film component to extend the life of existing systems.
In Japan & Korea 2004, we submitted several cardiographic products.
In Moscow-Russia 2005, we developed an application for the first RF infrared, non- invasive thermograph system. This Russian scientist in the Cold War could identify US submarines deep in the ocean from satellites orbiting the earth.
In Israel 2006, we developed clinical trials with a medical device inventor who developed non-significant screening device as an a adjunct to mammography.
In Saudi Arabia, 2008, on their request, we met with a delegation and proposed a method to implement a governmental agency to replicate the US medical device controls.
In India, 2009, we developed an application with a physician a new a low-cost disposable device for surgery.
In Canada in 1988, we assisted in the product launch of one of the worlds' first computerized electrocardiograms.
In Canada in 1995, we designed, created, prototyped, and manufactured a disposable tubing set to support clinical trails.
In Australia in 1995, we assisted a new product launch in Cardio logical Software. In England 1997, we submitted the second in history -Humanitarian Device Exemption for a life saving catheter.
In Dortmund - Germany, 1998, we developed an application for the first non- invasive blood glucose meter.
In China & Taiwan 2003, we developed products for lasers and low level light therapy devices.
In Argentina, 2004, we helped develop an upgrade existing fluoroscopic system to add a digital film component to extend the life of existing systems.
In Japan & Korea 2004, we submitted several cardiographic products.
In Moscow-Russia 2005, we developed an application for the first RF infrared, non- invasive thermograph system. This Russian scientist in the Cold War could identify US submarines deep in the ocean from satellites orbiting the earth.
In Israel 2006, we developed clinical trials with a medical device inventor who developed non-significant screening device as an a adjunct to mammography.
In Saudi Arabia, 2008, on their request, we met with a delegation and proposed a method to implement a governmental agency to replicate the US medical device controls.
In India, 2009, we developed an application with a physician a new a low-cost disposable device for surgery.
