Standards & Standards Development

Properly prepared test articles are critical for accurate biocompatibility testing. As a sponsor of a medical device, it is imperative for medical device manufacturers to understand what to do to ensure a successful test of a proposed medical device.

The industry was buzzing when Stryker announced in July that it would require its future suppliers of critical manufacturing processes to be accredited by MedAccred, a medical supply chain oversight program formed in 2010 by the Performance Review Institute.

Incoming AdvaMed chairman Nadim Yared will continue AdvaMed’s drive to ensure a permanent repeal of the medical device excise tax, calling it his “highest priority” heading into his term as chairman. Yared, who is president and CEO of CVRx, spoke at a press conference in April.

The Food and Drug Administration (FDA) is flagging a new technical information report (TIR) from AAMI that provides crucial guidance for “wireless coexistence” for a wide array of medical devices and systems.

The U.S. Department of Veteran Affairs (VA), Washington, DC, and UL (Underwriters Laboratories), Northbrook, IL, a global safety science organization, have signed a Cooperative Research and Development Agreement (CRADA) for current and emerging medical devices cybersecurity standards...

The Diabetes Technology Society recently announced its new cybersecurity standard for interconnected diabetes devices called DTSec. The standard specifies performance requirements utilizing the ISO/IEC 15408 framework used to define security requirements on “smart” medical...

According to the late, great David Bowie, “the stars look very different today”. After two years of collecting the 2.3% Medical Device Excise Tax, the tax has now been suspended for all of 2016 and 2017 when President Obama signed the Consolidated Appropriations Act of 2016. The tax was expected to raise almost $30 billion over...

IEEE, Piscataway, NJ, has announced a new standard and two new standards development projects designed to support plug-and-play, interoperable communications across eHealth devices. The new eHealth standard is IEEE 2410™-2015, Biometrics Open Protocol Standard,...

AAMI, the Association for the Advancement of Medical Instrumentation, is leading the small-bore connectors initiative, an international effort to decrease tubing misconnections and increase patient safety. Recently, AAMI has released two additional standards focusing on how to design connectors...