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QMSR Quick Take: Medtech Consultant Steve Silverman

 
• By Shawn M. Schmitt

Steve Silverman, a former compliance director for the US FDA’s device center, gives a quick take on the agency’s proposed Quality Management System Regulation. The QMSR would replace the FDA’s current Quality System Regulation.

QMSR Quick Take
• Source: Alamy

Steve Silverman is a former compliance director for the US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH). He’s now head of The Silverman Group, a consultancy for industry.

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MedTech Europe’s Bisazza Urges Action As US Tariffs Jeopardize Critical Global Supply Chains

 
• By Amanda Maxwell

The intricate assembly of medical devices, often involving over 1,000 globally sourced components, faces severe disruption due to new US tariffs. These barriers could halt production and devastate small and medium-sized enterprises (SMEs), MedTech Europe’s CEO, Oliver Bisazza, warns in an interview with Medtech Insight.

South Korea Adds Digital Health Rules To Already Complicated Regulatory Landscape

 
• By Elizabeth Orr

A New South Korean law, the Digital Medical Products Act, enhances regulation for digital health products. Medical devices in the country are categorized both by risk and by similarity to already authorized devices. The approval process may stretch to 515 days for new manufacturers.

Switzerland Investigates Private Sector Assessment of FDA-Approved Medical Devices

 
• By Amanda Maxwell

Its move comes as the Swiss recognize the need to ensure adequate supplies on medical devices in its country.

Medtech Seeks Inclusion In EU’s Groundbreaking Life Sciences Strategy

 
• By Amanda Maxwell

As the EU Life Sciences Strategy aims to drive innovation, the medtech sector is pushing for a pivotal role in a mission intended to embrace green and digital transitions, address regulatory obstacles and reduce dependency on external sources.

More from Policy & Regulation

New Guidance From Canada’s HTA Agency On Submission Of AI-Driven Evidence

 
• By Neena Brizmohun

Recognizing that the evidence it receives in applications for health technology assessments will increasingly be informed by artificial intelligence, the CDA-AMC has clarified its expectations for companies that use AI methods in the generation and/or reporting of evidence.

No FDA Reorg Planned, Makary Says

 
• By Elizabeth Orr

FDA Commissioner Marty Makary stated in a new interview that there will be no significant reorganization of the agency, despite earlier reports. Using his “guiding principles” of common sense and gold-standard science, he plans to focus on reforms including improved pathways for medical AI and food safety as well as addressing employee morale.

Medtech Seeks Inclusion In EU’s Groundbreaking Life Sciences Strategy

 
• By Amanda Maxwell

As the EU Life Sciences Strategy aims to drive innovation, the medtech sector is pushing for a pivotal role in a mission intended to embrace green and digital transitions, address regulatory obstacles and reduce dependency on external sources.