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Shawn M. Schmitt

Deputy Editor

Cape Coral, FL
Shawn M. Schmitt, deputy editor for regulatory and policy, lives and works in Cape Coral, Florida. 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, 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

Reimagining The 'Case For Quality': FDA Looking At More Hands-Off Approach, CDRH Director Shuren Says

In an effort to step back some from its role as a ringleader for the Case for Quality initiative, US FDA wants to create a "collaborative community" so various industry stakeholders can have a say in the six-year-old scheme that aims to drive a quality mindset throughout device manufacturing organizations.

Quality Control FDA

Warning Letter Roundup & Recap – Nov. 14, 2017

US FDA addressed quality systems and recall violations at the Florida maker of ProSun SunDream tanning beds in the only device-related warning letter posted this week.

Device Warning Letters Regulation

Compliance Corner: 20 Things You Should Never Say To An FDA Investigator

Medical device manufacturers might be tempted to defend themselves during a US FDA inspection. But longtime industry insider Steve Niedelman says there are 20 instances in which firms should remain tight-lipped.

Compliance Compliance Corner

'Program Alignment' Snaps Together: What's Next For US FDA's Inspection Scheme

Almost six months into its new "program alignment" inspection approach, FDA's initiative to inspect along commodity lines is still gaining its sea legs. A key FDA official says the agency is taking steps to train and retain specialized investigators. Meanwhile, FDA wants to use a geographic information system (GIS) tool to keep tabs on where investigators are inspecting.

Compliance Quality Control

Q3 Recalls Snapshot: Fewest Quarterly Recalls Since 2011; Sterility Troubles Dog Device-Makers

While overall medical device recall events fell 39% in the third quarter of 2017, recalled units ticked up slightly due to sterility problems. Check out our Q3 recalls infographic.

Recalls Quality

The Clock's Ticking: Tracking Global Regulatory Deadlines

The global regulatory environment for devices and diagnostics is rapidly evolving, with new frameworks, rules and directives rolling out around the world. To help keep up during this period of fundamental change, Medtech Insight has launched a new interactive timeline.

Regulation Compliance
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