Legacy medical devices face growing scrutiny as regulators push for stronger cybersecurity, transparency and risk management.

State licensing for prescription medical device manufacturers and distributors is a complex and evolving landscape. While FDA oversees federal regulations, individual states impose their own licensing ...

But as these products proliferate, manufacturers face a new set of questions. How do expectations around comfort, usability, ...

On February 2, 2024, the US Food and Drug Administration (FDA) published a much-awaited final rule: the Quality Management System Regulation (QMSR). 1 By issuing this rule, FDA amended the medical ...

Modern conveyance systems help medtech manufacturers achieve flexibility, compliance, and integration in smart factories.

Opinion: Medical device companies can create a competitive advantage by leveraging data to strengthen compliance programs and by ensuring effective oversight of quality and regulatory reporting ...

In a member webinar hosted by techUK, experts from the Medicines and Healthcare products Regulatory Agency (MHRA) provided a comprehensive introduction to the UK’s regulatory framework for software as ...

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In November, the Food and Drug Administration (FDA) held a Digital Health Advisory Committee meeting where it considered treating artificial intelligence mental health chatbots as medical devices. As ...

The U.S. Food and Drug Administration (FDA) categorizes medical devices into three classes based on the level of risk the devices pose to patients and users. Image Credit: IGORdeyka/Shutterstock.com ...

The U.S. Environmental Protection Agency (EPA) is proposing to loosen limits on emissions of ethylene oxide, a gas used to ...