Much concern has been expressed about whether the FDA may make changes to the 510(k) and other regulations that hinder speed to market for medical device companies. A recently finalized…
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The Healthy Skeptic is a website about the health care system, and is written by Kevin Roche, who has many years of experience working in the health industry through Roche Consulting, LLC. Mr. Roche is available to assist health care companies through consulting arrangements and may be reached at khroche@healthy-skeptic.com.