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Dec 28, 2023

FDA Guidance on Assessing the Credibility of Computational Modeling and Simulation: Factors, Goals, and Adequacy Assessment

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.

Dec 28, 2023

SAHPRA

SAHPRA Guidelines on Establishment Licensing: Costs, Documents, and Cooperation

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 Guidance on Assessing the Credibility of Computational Modeling and Simulation: Credibility Evidence Part 2

Dec 28, 2023

FDA

FDA Guidance on Assessing the Credibility of Computational Modeling and Simulation: Credibility Evidence Part 2

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.

Dec 28, 2023

BfArM

BfArM Guidance on Fast-Track Process for Digital Health Applications: Timeframes

The new article highlights the aspects related to the timeframes the applicants should follow.

FDA Guidance on Assessing the Credibility of Computational Modeling and Simulation: Credibility Evidence Part 1

Dec 28, 2023

FDA

FDA Guidance on Assessing the Credibility of Computational Modeling and Simulation: Credibility Evidence Part 1

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.

RegDesk Regulatory Roundup

FDA Guidance on Assessing the Credibility of Computational Modeling and Simulation: Factors, Goals, and Adequacy Assessment

SAHPRA Guidelines on Establishment Licensing: Costs, Documents, and Cooperation

FDA Guidance on Assessing the Credibility of Computational Modeling and Simulation: Credibility Evidence Part 2

BfArM Guidance on Fast-Track Process for Digital Health Applications: Timeframes

FDA Guidance on Assessing the Credibility of Computational Modeling and Simulation: Credibility Evidence Part 1

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