FDA
The article describes in detail the approach to be applied for credibility factors and credibility goals to be considered by the parties responsible for medical devices.
FDA
The new article highlights the aspects related to specific categories of credibility evidence the authority will expect medical device manufacturers to collect to demonstrate compliance with the relevant regulatory requirements, as well as the safety and proper performance of their products in general.
FDA
A comprehensive overview of three essential aspects of computational modeling: code verification results, model calibration evidence, and bench test validation results.
Each of these plays a vital role in ensuring the accuracy and reliability of computational models in various scientific and engineering domains.
FDA
The article describes in detail the approach to be applied when assessing the credibility evidence responsible parties are expected to submit.
FDA
The article provides a general overview of the guidance document issued by the US authority and highlights the key points related to the existing legal framework.
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.
