FDA
The new article highlights the aspects related to the general regulatory framework for computational modelling and simulations used in the healthcare sphere in the context of medical device development.
BfArM
The new article highlights the aspects related to the timeframes the applicants should follow.
EDA
The article provides a general overview of the existing regulatory framework associated with adverse events.
FDA
The new article highlights the aspects related to design considerations including control mechanisms to be implemented. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has...
FDA
The article highlights the key points related to the regulatory status of the products based on the existing legal framework. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has...
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