“Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions | FDA” is a new document produced by the FDA that provides...
The article highlights the key points associated with factors to be considered when determining the eligibility of a medical device type for a third-party...
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 article highlights the key points related to notification requirements medical device manufacturers should follow with respect to possible discontinuance or interruption in the...
The article describes in detail the approach to be applied for credibility factors and credibility goals to be considered by the parties responsible for...
The new article highlights the aspects related to the way animal studies should be planned and conducted, including the facility selection, as well as...
The new article provides an overview of the new guidance document dedicated to the processes and procedures associated with the review of certain regulatory...
The new article highlights the key points related to the specific aspects of selecting proper predicates to demonstrate compliance with the applicable regulatory requirements...
