Stability studies measure how medical devices respond to environmental stresses such as temperature, humidity, light, and ...

Airborne ultrasound enables non-destructive seal monitoring, detecting subtle material variations. See how this proactive ...

The digital revolution that resulted in the Internet of Things (IoT), Internet of Medical Things (IoMT), Software as a Medical Device (SaMD), and connected devices permeating the healthcare ...

Artificial intelligence (AI) and machine learning (ML) are redefining healthcare, from enabling earlier diagnoses and personalized treatments to streamlining hospital operations and accelerating ...

Cardiovascular diseases are responsible for over 15 million deaths worldwide per year. 1 The occlusion of vessels such as the coronary or peripheral arteries hinders the flow of blood to the heart, ...

The FDA proposed on Feb. 22, 2022, an update to the Quality System Regulation 1 that was released in 1996. The proposal is to reference ISO 13485:2016 Medical devices — Quality management systems — ...

Pressures on healthcare systems are set to become worse with aging populations requiring round-the-clock care and an exponential increase in chronic diseases. Technology-led smart solutions are ...

The European Union’s Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746) impose stringent requirements on all economic operators involved in the supply chain of ...

Periodically, standards are revisited by international and national committees to determine if they are still current or need revision or withdrawal. Through the voting process and based on comments ...

In my first article, I discussed the background and a few high-level observations of the FDA’s summaries of its medical device quality system inspections. This article digs into the details, starting ...

Human factors engineering (HFE) must be considered by every medical device manufacturer at some phase of the design and development journey to ensure the end product can not only gain FDA approval but ...