Medical Device Regulatory & Engineering Blog

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

Whether you’re entering a new market, transitioning from hardware to software, adding software to a product, or moving to a new eQMS solution, the SxMD ...

In the dynamic landscape of modern product development, two distinct methodologies have long held the reins: Application Lifecycle Management (ALM) and Product Lifecycle Management (PLM). ...

Getting your medical device to market is not simple. It's a journey that requires careful planning, meticulous attention to detail, and a deep commitment to ...

In the world of Software as/in a Medical Device (SxMD), design and quality processes play a pivotal role in delivering safe and effective software products. ...

When Ann started her Bio-engineering degree, she had a clear goal: specialize in medical technology. After completing her PhD, she found herself at a crossroads. ...

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. ...

AI is outpacing Moore’s law at a staggering rate and notably, the 2023 AI Index Report shows the focus area with the most investment was ...

We are excited to provide you with a better experience when accessing MatrixReq. We have carefully redesigned our website to ensure effortless access to the ...