Minnetronix | Minneapolis Medical Device Manufacturer

Industry Insights / Steve Strong

Regulatory Update: Conflict Materials Legislation

by Steve Strong, VP of Quality & Regulatory Affairs Publication: February 2013: Vital Signs Minnetronix Newsletter

Recently, there has been much discussion regarding “Conflict Materials” legislation, which effectively requires publically traded medical device manufacturers to disclose their use of conflict materials, or materials originating in the Democratic Republic of the Congo (DRC) or an… more

The Ever-Changing Regulatory Environment

by Steve Strong, VP of Quality & Regulatory Affairs Publication: August 2011: Vital Signs Minnetronix Newsletter

An overview of recent initiatives from the FDA’s Center for Devices and Radiological Health (CDRH) to improve the 510(k) process, and the release of seven guidance documents that have broad impact on the medical device industry.