Nov 3, 2022
Brazil
The new article described in detail the aspects related to the evidence required for software products based on novel technologies, as well as to the determination of the regulatory status of the products depending on their functions and features. The Brazilian...
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Oct 27, 2022
Brazil
The article provides an overview of the regulatory requirements for software as a medical device in Brazil. The Brazilian regulating authority in the sphere of medical devices (ANVISA), has published a questions and answers document dedicated to the regulatory...
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Nov 11, 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 postmarket management of cybersecurity in medical devices. The document is intended to provide...
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Nov 5, 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 cybersecurity matters related to medical devices. Among other aspects, the guidance addresses the...
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Nov 1, 2020
FDA
The Food and Drug Administration (FDA) has published a discussion paper dedicate to the cybersecurity vulnerabilities associated with medical devices. In particular, the document describes the best practices to be considered when communicating with the healthcare...
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