Medical Device Regulatory & Engineering Blog

In this article, I will describe the advantages of the microservices architecture when writing code for medical devices and AI software, drawing on my event-driven ...

The heaviest implications of the AI Act on providers of High-Risk AI systems are associated with the preparation of the Technical Documentation (discussed in the ...

In the world of Software as/in a Medical Device (SxMD), staying ahead means embracing change. That's why we're thrilled to announce our latest release – ...

Guaranteeing the quality and safety of a product is the key to success for any business. For medical device development, where precision and safety are ...

In this blogpost we aim to outline the requirements of the AI Act with regards to Technical Documentation and investigate the relation between the AI ...

There are lot's of names used in different regulations and standards to describe software components not developed according to your own IEC 62304 inspired processes. ...

In the rapidly evolving landscapes of artificial intelligence (AI) and medical technology, the imperative for robust regulatory frameworks is more critical than ever. Both fields ...

Preparing for Medical Device Regulation (MDR) certification is a multifaceted process that involves careful planning and comprehensive adherence to regulatory requirements. Here are five main ...

Choosing an ALM system for medical device software comes down to one test. Short answer: pick the application lifecycle management tool that keeps the ISO ...