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Shawn M. Schmitt

Executive Editor

Miami, FL
Executive Editor Shawn M. Schmitt lives and works in Miami. For more than two decades he has written and edited for various high-profile media outlets, including The New Republic and London's Independent Television News (ITN). Since 2005 he has reported on medical device quality control, compliance and post-market issues. A spirited, creative journalist, Shawn reported from the White House Rose Garden for Counseling Today, met with medical device experts in Costa Rica for Medtech Insight, traveled the US to get the scoop on Medicare funding for DecisionHealth, and wrote about the proliferation of nuclear weapons for National Journal's Global Security Newswire. Shawn holds a Master of Arts in Communication: Journalism and Public Affairs from American University in Washington, D.C. (2004), and a Bachelor of Arts in Journalism and Communications from Point Park University in Pittsburgh (1997).

Latest From Shawn M. Schmitt

Device Week, 18 September 2020 – Keeping The ‘Human’ In Human Factors Amidst COVID-19

In the age of coronavirus, human factors professionals are doing their best to find their way through the pandemic by putting unique twists on usability testing to see what works and what doesn’t in the new reality. That’s the topic of this week’s podcast.

Device Week Safety

Human Factors Experts Forge Ahead With ‘Tricky’ In-Person Studies In The Age Of Coronavirus

Sanofi usability expert Molly Story and other longtime human factors professionals detail some extraordinary measures they’re taking to keep study participants and moderators safe, from the simple (masking up) to the more extreme (using separated testing rooms). Also: the US FDA weighs in on remote testing.

Safety Clinical Trials

Warning Letter Roundup & Recap – 16 September 2020

Two companies were sent FDA warning letters for selling adulterated COVID-19 tests, while a third was dinged for selling its transilluminator device for breast evaluation without agency approval or clearance.

Device Warning Letters FDA

Top FDA Official: Agency ‘Creative,’ ‘Efficient,’ ‘Focused’ After COVID-19 Domestic Inspection Hiatus

William Maisel says FDA investigators are putting their best foot forward when conducting facility inspections amidst the coronavirus pandemic.

FDA Enforcement

Another Delay On The Way? FDA’s Shuren Says Industry Should ‘Anticipate’ QSR Harmonization To Take ‘Little While Longer’

Jeff Shuren, director of the US FDA’s device center, signaled on 15 September that the agency might not have the hotly anticipated draft of its retooled Quality System Regulation ready for release by next month.

Quality Regulation

AAMI Targets Costa Rica Regulatory, Quality Professionals For Education

The Association for the Advancement of Medical Instrumentation is launching a slate of educational programs for medtech regulatory and quality assurance professionals in the Latin American country.

Costa Rica Regulation
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