The article highlights the aspects related to the key considerations for methodologies used in the context of the collection and analysis of real-world evidence.
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The FDA recently announced release of final transition guidance documents for medical diagnostic devices targeting COVID-19. The transition guidance documents are intended to guide COVID-19...
Cybersecurity is a key consideration in today’s market for medical device manufacturers and other industries. I have previously written about the FDA’s expectations for...
The U.S. Food and Drug Administration (FDA) is partnering with Health Canada to launch a joint electronic Submission Template and Resource (eSTAR) pilot.The joint...
The new article highlights the aspects related to the changes to registered medical devices implemented in response to adverse events, the context of field...
The new article provides an overview of the medical device classification rules adopted in the European Union and highlights the key points associated thereto.
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The new article highlights the approach to be applied concerning counterfeit medical devices, as well as the way the parties involved should handle complaints...
