Dec 21, 2021
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to the content of premarket submissions for device software functions. Table of Contents The document is...
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Sep 13, 2019
North America
FDA’s Center for Devices and Radiological Health (CDRH) holds a meeting to discuss the risks and threats of cybersecurity in medical devices. They describe the unique challenges involved with security and how difficult it is to identify vulnerabilities. The Threat...
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Sep 9, 2019
EU MDR/IVDR
British medical products regulating authority, the MHRA, issued a special guidance describing the impact Brexit could have on medical device regulations. The guidance describes the consequences of Brexit to all parties involved in medical device development,...
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Apr 18, 2019
North America
The US Medical Device regulating authority, the Food and Drug Administration (FDA), has issued a Safety Communication to warn all potential users on risks associated with the use of unapproved diagnostic medical devices. The Products A current, focal concern is...
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Jul 12, 2016
North America
As the benefits of software become increasingly present to healthcare systems, its risks do too. While software can increase the efficiency and effectiveness of healthcare, it can also create greater vulnerabilities. The medical device industry in particular has had...
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