The new Regulations for medical devices and in vitro diagnostic devices create a more robust, transparent, and sustainable regulatory framework. In this article, we will tell you all you need to know to be up to date to the new requirements implemented by the European Commission.
Increasing patients’ safety and care in research is vital when preparing and conducting your study. From a HEMEX perspective, we are tackling in this article four important points you should consider during the process.
Market tracking is not only exciting but has recently become a requirement under the Medical Device regulations (MDR) of the EU. Join us in learning what steps are necessary to complete the post-market clinical follow-up!
In the battle of fighting against COVID-19, a rapid test is crucial to understand the spread of the pandemic. The Swiss start-up LiVET that originally developed diagnostic tests for respiratory diseases in horses has accelerated their platforms to detect COVID-19 in human samples, establishing a newly incorporated company ender diagnostics ag. Undeniably, ender is a […]
On 31 December 2019, the World Health Organization (WHO) received the first case report about pneumonia of unknown cause in Wuhan, China1. Despite draconian containment measures such as lockdown and air travel bans in many countries, as of 4 June 2020, the COVID-19 pandemic has caused more than 6.6 million infections worldwide and the death […]
We are delighted to welcome Hi-D Imaging AG to our growing list of portfolio companies and are pleased to support them as a strategic clinical and regulatory development partner. Hi-D Imaging AG, an ETH Spin-off medtech company founded in July 2019, aims to revolutionize the cardiovascular sector by making personalized aortic heart valve replacement therapy […]