Medical Device Regulatory & Engineering Blog

First a brief note regarding the AI Act itself, which has now passed its final approval vote by the European Parliament. A new version of ...

Regulatory affairs and Quality assurance (RAQA) is a complex journey. Becoming an expert in RAQA takes time. Regardless of where you are at this moment ...

How can we navigate the complexities of medical device development? The journey is fraught with challenges. As we seek to introduce innovative medical devices to ...

At MatrixReq, we understand that the key to groundbreaking innovation and unparalleled efficiency lies in constantly refining our solutions to meet the intricate demands of ...

Before 2017, there were 3 directives in Europe linked to differend kinds of medical devices: one being the Active Implantible Medical Device Directive (AIMDD), another ...

What distinguishes a utility patent from a design patent? Both types of patents protect innovative concepts, yet they cater to fundamentally different aspects of a ...

On February 2 2024, FDA published a final rule that describes an update of the 21 CFR Part 820, which describes the requirements for Quality ...

Imagine a world where every medical device can be tracked to its origin with just a few clicks. What happens when this traceability becomes not ...

The medical device industry is evolving rapidly, driven by innovation and stringent regulatory requirements. One critical aspect that manufacturers must master to ensure both compliance ...