Skip to content

Knowledge

BreakfastandLearn

Regulation of software as a medical device: risk class and process steps

Available in VIDEO! Regulatory roadmap necessary to configure, validate and launch a software as a medical device (MD) in the 10th Breakfast&Learn of the TECSAM Network. Dominique Monferrer, Medical Device Director at Asphalion, showed us the classification of the software according to the risk class and the stages of the regulatory process. Don’t miss it!

Breakfast and Learn

Regulation of the software as a medical device

On Wednesday, September 14 at 9 a.m., we return after the summer break with the Network's 10th Breakfast&Learn, where we will have the Asphalion expert, Talyta Carteano, to address the specific regulation that governs the software as a medical device and the criteria to be taken into account to validate and bring these products to market. Sign up!

From the idea to the market: spin-offs created from mental health research

From the idea to the market: spin-offs created from mental health research

On Wednesday 6 July, we celebrate the 9th Breakfast & Learn of the TECSAM Network. In this virtual day we will bring together three researchers in the field of mental health who have created spin-offs or are about to do so. We will reflect on the next steps, the difficulties, the main allies and the challenges. Sign up for this new B&L event!

BL8

The purpose of the medical device, a key element to define its regulation

How does medical device regulation work? From the hand of Talyta Carteano, an expert from Asphalion, we have been able to learn about the European regulation that governs these technologies and the process to be followed by researchers to launch them on the market, at the Network's VIII B&L. Did you miss it? Read our blog post!

Medical devices and their regulation: what do we need to know?

Medical devices and their regulation: solving doubts

On Wednesday, 1 June at 9 a.m., we celebrated the 8th Breakfast & Learn of the TECSAM Network, where we will learn to identify what is and what is not a medical device, and we will examine the regulation governing these technologies.