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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

Compliance Corner: The 10 Best – And 10 Worst – Things You Can Do When FDA Inspects Your Firm (Part 5)

A panel of longtime industry experts offer manufacturers a list of things they should and shouldn’t do when an investigator from the US agency knocks on their facility door. In this fifth installment of a 10-part series, the experts address so-called front rooms used by manufacturers during an inspection.

Compliance Corner FDA

Compliance Corner: The 10 Best – And 10 Worst – Things You Can Do When FDA Inspects Your Firm (Part 4)

A panel of longtime industry experts offer manufacturers a list of things they should and shouldn’t do when an investigator from the US agency knocks on their facility door. In this fourth installment of a 10-part series, the experts address so-called back rooms used by manufacturers during an inspection.

Compliance Corner FDA

‘Immediately Discontinue’ Using Potentially Nonsterile Surgical Gowns, Packs From Cardinal Health, FDA Warns; Company Assessing Quality Issues

The US agency is telling health-care providers to yank specific gowns – and procedural packs that contain the gowns – from shelves because their maker, Cardinal Health Inc., cannot assure their sterility. The agency is also warning that the problem could lead to a shortage of so-called Level 3 gowns, which are used in a wide-array of everyday surgical procedures.

Recalls Quality

Compliance Corner: The 10 Best – And 10 Worst – Things You Can Do When FDA Inspects Your Firm (Part 3)

A panel of longtime industry experts offer manufacturers a list of things they should and shouldn’t do when an investigator from the US agency knocks on their facility door. In this third installment of a 10-part series, the experts address the do’s and don’ts of responding to investigator requests for information and records.

Compliance Corner FDA

Q3 Recalls Snapshot: Number Of Recalls Ticks Up For Third Consecutive Quarter; Recalled Units Spike An Incredible 1013%

Device makers initiated 243 recalls in the third quarter of 2019 – a modest 1% increase over Q2’s 200 recalls. Interestingly, the number of recalled device units skyrocketed a whopping 1013%, from 19.7 million in Q2 to 219.2 million in Q3. Check out our Q3 recalls infographic.

Recalls FDA

Compliance Corner: The 10 Best – And 10 Worst – Things You Can Do When FDA Inspects Your Firm (Part 2)

A panel of longtime industry experts offer manufacturers a list of things they should and shouldn’t do when an investigator from the US agency knocks on their facility door. In this second installment of a 10-part series, informational slide decks used during an inspection's opening meeting are discussed by former FDA officials David Elder and Steve Niedelman.

Compliance Corner FDA
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