RegDesk Regulatory Roundup

Dec 28, 2023

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.

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

Dec 28, 2023

FDA

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

The article describes in detail the approach to be applied when assessing the credibility evidence responsible parties are expected to submit.

FDA Guidance on Assessing the Credibility of Computational Modeling and Simulation: Introduction

Dec 20, 2023

FDA

FDA Guidance on Assessing the Credibility of Computational Modeling and Simulation: Introduction

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 Guidance on Assessing the Credibility of Computational Modeling and Simulation: General Framework

Dec 20, 2023

FDA

FDA Guidance on Assessing the Credibility of Computational Modeling and Simulation: General Framework

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.

FDA Guidance on General Considerations for Animal Studies: Study Design

Dec 20, 2023

FDA

FDA Guidance on General Considerations for Animal Studies: Study Design

The new article highlights the aspects related to the design of animal studies involving medical devices to be considered by the responsible parties in order to ensure the accuracy and reliability of the results.

Dec 20, 2023

FDA

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

The article describes in detail the approach to be applied when assessing the credibility evidence responsible parties are expected to submit.

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RegDesk Regulatory Roundup

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

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

FDA Guidance on Assessing the Credibility of Computational Modeling and Simulation: Introduction

FDA Guidance on Assessing the Credibility of Computational Modeling and Simulation: General Framework

FDA Guidance on General Considerations for Animal Studies: Study Design

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

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