Regulatory Compliance Archives

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: 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.

Dec 19, 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.

RegDesk Regulatory Roundup

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

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

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

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REGDESK HAS BEEN RECOGNIZED AS A REPRESENTATIVE VENDOR IN TWO RECENT GARTNER MARKET GUIDES: