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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

Compliance Corner: Leverage MDSAP Companion Doc To Master Your Next Audit, Train Staff, Expert Advises

Longtime industry expert Connie Hoy says medtech companies that sign up for an audit through the Medical Device Single Audit Program will have a leg-up if they prepare beforehand by reading the MDSAP Companion Document. The doc can also be used to train workers on what an MDSAP auditor will be looking at and asking for.

Compliance Corner Enforcement

Warning Letter Roundup & Recap – 23 June 2020

Four enforcement letters were sent by the US FDA to makers of adulterated COVID-19 serology tests.

Device Warning Letters FDA

At Long Last, ISO Publishes Risk Management Standard Companion Doc TR 24971

Roughly six months after releasing an updated version of its risk management standard ISO 14971, the International Organization for Standardization (ISO) has published companion document Technical Report 24971.

Risk Management Standards

3 Companies Warned By FDA For Marketing Adulterated COVID-19 Antibody Test Kits

The warning letters sent to Medakit Ltd., antibodiescheck.com and Sonrisa Family Dental are the first enforcement missives sent by the US agency related to false or misleading marketing for the serological tests, which can detect if a person is infected with the SARS-CoV-2 virus, or had the disease in the past.

FDA Enforcement

FDA To Makers Of EUA Devices: Don’t Forget To Report Adverse Events

Manufacturers of devices granted emergency use authorization (EUA) status during the COVID-19 crisis are fully responsible for filing any adverse events about the products to the FDA, the US agency says on a new FAQ page.

FDA Compliance

Warning Letter Roundup & Recap – 16 June 2020

The FDA instructed a device maker to hire a consultant to audit its “manufacturing and quality assurance systems” in the only device-related warning letter released by the US agency this week.

Device Warning Letters FDA
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