Medical Device Regulatory & Engineering Blog

Artificial Intelligence (AI) introduces risks, risks that are new and risks that can affect the human population at a large scale. Industry leaders even have ...

In the regulated world of medical devices, document control is key. One of the aspects of document control is controlling the signatures on those documents ...

As in many other industries too, Software as a Medical Device (SaMD) solutions have become an integral part of the medical device industry. While the ...

In Medtech and Healthcare technology the introduction of groundbreaking medical devices is revolutionizing patient care. However, overcoming the regulatory burden is a huge challenge. Leverage ...

In the previous blogpost we assessed the developments around the upcoming AI Act. Since the agreement between the European Parliament and the European Council the ...

In this post, we will zoom in on the IEC 62366 standards which provides requirements for usability engineering for medical devices. In order to understand ...

In the ever-evolving landscape of medical device development, ensuring the safety and efficacy of software is paramount. The International Electrotechnical Commission (IEC) has established standards ...

In this blog series, we dive into the specifics of ISO 14971, the pivotal standard governing risk management of medical devices. Whether you're a seasoned ...

At the beginning of the year, we published an article on the AI Act's development, shedding light on the advancements in shaping the regulatory framework ...