May 23, 2018

“Stated simply, we formulate the goop, we buy all the raw materials to mix the goop” ….. Fine, here’s your warning letter.

Every ‘small company’ likes to proclaim it’s uniqueness and the astute one’s do it simply – providing a direct yet compelling message on their website.  One […]
April 23, 2018

Are We Inadvertently Stifling Innovation?

By: RinaWolf I recently had the opportunity to speak with an international company about what it takes to bring a new diagnostic test to market in […]
March 15, 2017

Differences in the Controls Between Class I

The distinguishing factor between whether a device can be designated as a Class I, Class II, or Class III device is based on the safety and […]
March 1, 2017

Sponsored Prior Authorization Services

Several large manufacturers currently offer prior authorization services for certain product lines. Why would they do this given the cost and regulatory exposure? Obviously, they believe […]
February 13, 2017

Strategic Classification of Your New Medical Device Technology

Never is it too soon to contemplate the regulatory strategy of a new medical device technology.  Several considerations should be considered early in the strategic development […]