On December 29, 2022, President Biden signed a new statute that will significantly impact medical device cybersecurity regulation. Section 3305 of the Consolidated Appropriations Act of 2023 (“Section ...
Cyberattacks and data theft are a serious problem in many industries, but in healthcare the consequences could be physically dangerous or even deadly or enrich the pockets of bad actors on the dark ...
Changes affecting the approval of medical devices in Canada are coming. Health Canada has released a notice on Proposed Changes to the Guidance on Recognized Standards for Medical Devices along with a ...
January 13, 2026 - PRESSADVANTAGE - In the highly regulated field of medical device labeling translation, ensuring that ...
Medical software is the backbone of modern healthcare, supporting electronic health records (EHRs), diagnostic systems, imaging technologies and embedded software in medical devices like pacemakers ...
Already this year, major medtech makers including BD, Insulet and Zoll Medical have all alerted their customers to cybersecurity vulnerabilities in their medical devices that could potentially ...
Medical devices with artificial intelligence (AI), machine learning (ML), and similar “intelligent” systems come with additional layers of quality and regulatory scrutiny. In addition to proof of ...
A test technician prepares for an EMC test in a 10-m semianechoic chamber. Use of a semianechoic chamber is necessary for the immunity testing required under EN 60601-1-2:2001 for applicable medical ...
As countries sought quick access to medical devices during the COVID-19 pandemic, they ran into roadblocks associated with different regulatory standards. These differences hampered China’s ability to ...
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