WoundExam realizes the critical importance that regulation has within the health care and insurance industries.  Various regulatory bodies protect the public at every level: from pre-empting health risks to providing numerous programs for public health and welfare.  While healthcare regulations are developed and implemented at all levels of government (federal, state, and local), private organizations play an important role, especially in advancing the appropriate, and state-of-the-art care for patients.

WoundExam is taking the approach of 510(k) with the FDA for the United States.  All registered medical devices in the USA need to register with the US FDA, although rigor varies between product types.  Class I devices can be self-registered, but Class II filings require 510(k) submission. WoundAssure is taking the most appropriate class of device based on our expert FDA regulatory team’s experience from successfully launching a broad array of devices.

There are many grant funding opportunities to assist in financing the final development and commercialization of the WoundAssure systems. Our team has extensive experience and past successes in applying and being awarded similar grants through NIH, DARPA, NIST and many other government organizations.

There are many grant funding opportunities to assist in financing the final development and commercialization of the WoundAssure systems. Our team has extensive experience and past successes in applying and being awarded similar grants through NIH, DARPA, NIST and many other government organizations.