Medical Devices and Pharma
Medical device and pharmaceutical regulatory consulting and health safety informationWelcome to Medical Devices and Pharma, a website dedicated to providing timely and relevant medical device and pharma information to the regulated medical device and pharmaceutical industries, and consumers of those products.
Our goal is to provide organized, clearly written information from regulatory affairs and consumer perspectives.
- Key information from the Food and Drug Administration (FDA), the federal regulatory agency responsible for providing oversight over the industries and assuring the safety and efficacy of their products.
- Regulatory services for compliance, market access, and crisis management
- Information about innovation, including new products cleared for use in the U.S. market.
- News stories with topics ranging from product issues to market trends.
Perhaps most importantly, we will strive to maintain vigilance over product issues and their impacts. Check back here for consumer news, product alerts, and current litigation.
Medical Devices
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The Latest Posts
How Unsafe Medical Devices Can Slip Through the Cracks
Healthcare professionals and the device industry share responsibility for timely adverse event reportingGlobal device market withdrawals not always followed in US In a world of global trade and instant communication, you might assume that a medical device deemed...
Study Reveals Delays in Medical Device Adverse Event Reporting
Healthcare professionals and the device industry share responsibility for timely adverse event reportingLapses defeat the purpose of adverse event reporting A recent study published in the British Medical Journal has spotlighted a troubling trend: many medical device...
QMSR Strategy for US Companies with QSR and ISO Compliance
QMSR Implementation Strategy for U.S. Medical Device Manufacturers Compliant with the QSR and ISO 14385:2016 If your company is already compliant with the QSR and ISO 13485:2016, you’re ahead of the curve in the transition to FDA’s Quality Management System Regulation...
A QSR to QMSR Transition Strategy
QMSR Implementation Strategy for U.S. Medical Device Manufacturers Not in Compliance with ISO 14385:2016 Transitioning from the FDA’s Quality System Regulation (QSR; 21 CFR 820) to the Quality Management System Regulation (QMSR) is a significant undertaking that...
QSR-to-QMSR Paper Gap Audit
Is Your Quality System Really Ready for QMSR? As FDA’s transition from the QSR to the QMSR approaches, many medical device manufacturers are discovering that “substantially equivalent” doesn’t mean “completely aligned.” Even companies with solid QSR documentation are...
Postmarket Surveillance – from QSR to QMSR
How QSR Postmarket Surveillance Will Evolve Under the QMSR As medical device manufacturers transition from the FDA’s Quality System Regulation (QSR) to the new Quality Management System Regulation (QMSR), one area undergoing significant change is postmarket...