Medical Device Regulatory & Engineering Blog

The European Commission first drafted the AI Act in April 2021 with the intention to set out a common regulatory and legal framework for Artificial ...

In the ever-evolving landscape of Medical Devices, ensuring quality, consistency, and compliance is paramount for sustainable growth. One crucial aspect that plays a pivotal role ...

ISO 13485 isn't just another hoop to jump through; it's your ticket to credibility and compliance in the fiercely regulated world of medical devices regulated ...

In the world of medical device development, there are two essential pillars that every team must master in order to bring their Medical Devices to ...

In today's dynamic software development landscape, delivering top-notch SxMD products demands a streamlined approach that allows teams to work on multiple product releases, multiple versions, ...

The landscape of regulatory standards in the medtech industry is dynamic, with many updates that respond to advancements in technology, scientific discoveries, and the evolving ...

We are thrilled to announce upgrades to our widely popular Jira addon. These powerful enhancements help you manage your workflow, providing unparalleled visibility and efficiency. ...

Paris, 1 November 2023, MatrixReq and MD101 are pleased to announce they have entered into a strategic partnership, combining MatrixReq expertise as a leading platform ...

Entrepreneurs and startups within the Medtech and Medical Devices industry are often in the dark when it comes to the regulatory approval process. This article ...