RegDesk Regulatory Roundup -- Medical Device and Pharma

Dec 28, 2023

MDA Guidance on Advertisement Approval: Application Details

The article highlights the aspects related to the information to be included in the application an interested party should submit.

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.

Dec 28, 2023

BfArM

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

The article highlights the aspects related to the life cycle of the digital health applications included in the respective directory.

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.

Dec 20, 2023

SAHPRA

SAHPRA Guidelines on Establishment Licensing: Introduction

The article highlights the key points related to the licensing regime for medical device establishments.

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.

RegDesk Regulatory Roundup

MDA Guidance on Advertisement Approval: Application Details

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

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

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

SAHPRA Guidelines on Establishment Licensing: Introduction

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

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