Medical Device Regulatory & Engineering Blog

The US National Telecommunications and Information Administration (NTIA) convened a multi-sector initiative of various stakeholders in 2018 to discuss software transparency. One output was the ...

Before starting to develop your software you need to write a software development plan, describing all the processes and design outputs you put in place ...

In January, we published our first article on the AI Act and its impact on the Medical Device field. It's important to note that crafting ...

The medical device industry is undergoing a seismic shift with the introduction of the new Medical Device Regulation (MDR) in the European Union. As manufacturers ...

The European Union (EU) was once the market of choice to launch new medical device technology. The regulatory system, implemented through a partnership between governments ...

As a Medical Device company, one of your top priorities should be ensuring compliance with regulations and industry standards. The consequences of non-compliance can be ...

When it comes to developing software solutions for Medical Devices, many companies consider using in-house software tools to save on costs and improve convenience. However, ...

When designing the software for medical devices, the top priority is the safety of the patient, physicians and other involved people. In other, less regulated, ...

Software testing is one of the key pillars of development and is based on best practices. One of the general assumptions is that shorter tests ...