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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).
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Latest From Shawn M. Schmitt

FDA Mulls Variant CMMI Maturity Model Program For 'Struggling' Device Companies

Device-makers that are shut out of the US agency's Case for Quality Voluntary Improvement Program (CFQ VIP) because of poor compliance histories may soon be able to join an alternative initiative that would use an industry-tailored version of the Capability Maturity Model Integration (CMMI) framework to assess manufacturing maturity and quality.

Quality FDA

Warning Letter Roundup & Recap – 17 September 2019

In the only device-related warning letter released by the US FDA this week, the maker of Bounder wheelchairs was cited for premarket and Medical Device Reporting violations.

Device Warning Letters FDA

Device Week, 13 September 2019 – Feathering The NESTcc

In this week’s Medtech Insight podcast, senior reporter Elizabeth Orr gives the skinny on the latest developments surrounding the National Evaluation System for health Technology Coordinating Center, or NESTcc.

Device Week FDA

Q2 Recalls Snapshot: It's A Mixed Bag For Industry As Recall Events Jump Slightly And Recalled Units Fall Dramatically

There were 200 recalls initiated by device-makers in the second quarter of 2019, a 22% increase over Q1, when 164 were reported. Conversely, the number of recalled device units fell from 135 million in Q1 to 19.7 million in Q2 – a decrease of 85%. Check out our Q2 recalls infographic.

Recalls Safety

FDA's Quality System Regulation Is Mapped To International Standard ISO 13485 – And Vice Versa – In New Report From AAMI

A new Technical Information Report (TIR) from the Association for the Advancement of Medical Instrumentation compares regulatory requirements found in the US FDA's QSR to those in quality systems standard ISO 13485:2016. While the 146-page document is aimed at US device-makers, it could also be helpful to the FDA as the agency works to harmonize its QSR with the ISO standard.

Regulation Standards

US Regulatory Roundup, August 2019: Safety And Compliance Take A Front Seat

Concerns about paclitaxel-coated balloons and stents, as well as recalls linked to two large device manufacturers, captured the attention of many of our online readers last month, as did compliance-focused features that offered tips and advice from US FDA officials. Here are August's 10 most popular US regulation and policy stories from Medtech Insight.

United States Regulation
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