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.
SAHPRA
The new article highlights the aspects related to the costs associated with establishment licenses, and supporting documentation interested parties should submit, and also explains cooperation between different regulating authorities and bodies.
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.
BfArM
The new article highlights the aspects related to the timeframes the applicants should follow.
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.
Malaysia
The article highlights the aspects related to the information to be included in the application an interested party should submit.
