Day: July 17, 2023

Welcome to our comprehensive guide on 510(k) clinical studies. For those in the medical device industry, 510(k) clinical studies are a critical aspect of the regulatory approval process. This section will provide you with an in-depth understanding of what 510(k) clinical studies are, their regulatory framework, and their role in evaluating medical devices.

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Insight on 510(k) Clinical Studies: An In-depth Guide

Welcome to our comprehensive guide on 510(k) clinical studies. For those in the medical device industry, 510(k) clinical studies are a critical aspect of the

17 July 2023

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Decentralized Clinical Trials (DCT): A Revolutionary Approach in Research

Decentralized Clinical Trials (DCT) represent a groundbreaking approach to research, transforming the way studies are conducted and making them more efficient, patient-centric, and accessible. This

17 July 2023

Explore IVD Clinical Performance Studies and their crucial role in advancing diagnostic testing accuracy. Empowering science, improving healthcare.

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Understanding the Significance of IVD Clinical Performance Studies in Diagnostic Testing

The field of diagnostic testing has come a long way in recent years, thanks in large part to the advent of in vitro diagnostics studies. Commonly

17 July 2023

The Regulation EU 2017/745, commonly known as the Medical Device Regulation (MDR), came into effect on May 26, 2021, bringing with it new requirements for clinical and post-market data for medical devices in Europe. One significant addition was the implementation of the Clinical Evaluation Consultation Procedure (CECP) as an extra level of scrutiny for specific devices.

Introduction to the EU MDR and the Clinical Evaluation Consultation Procedure (CECP)

What are the major changes introduced by the EU MDR compared to previous regulations? The Regulation EU 2017/745, commonly known as the Medical Device Regulation (MDR),

17 July 2023