Shawn M. Schmitt
Latest From Shawn M. Schmitt
In this episode of Speaking Of Medtech we’re breaking out the crystal ball to give a few predictions of what could be in store this year for industry and the US FDA’s Center for Devices and Radiological Health. From the ongoing COVID-19 pandemic to digital devices and facility inspections, there’s a lot of ground to cover.
On this week’s podcast: From Hawaii to Missouri to Florida, the medtech industry and third-party servicers are duking it out in state legislatures over who has the right to repair and service medical devices.
Manufacturers keen on fostering a culture of quality throughout their organizations should first make sure they have a robust quality strategy in place. Here, BD’s VP of quality management & supplier quality answers a handful of questions on the topic.
The goal of the guidance is to make the Case for Quality Voluntary Improvement Program, or CfQ VIP, “more official” at the US FDA, an agency official says. CfQ VIP aims to elevate product, manufacturing and process quality at medical device firms.
The US FDA on 11 January issued a safety alert that the diagnostics made by LuSys Laboratories could give false-positive or false-negative results. The agency has asked health care providers and others to stop using the tests.
It’s been several years in the making, but the US FDA has finally sent its retooled QSR to the White House Office of Management and Budget for review. The agency has been working on harmonizing its QSR with quality systems standard ISO 13485 since 2018.