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 ...

AI-assisted symptom recognition and pattern matching leverages machine learning to analyze vast amounts of medical data, including patient histories, clinical notes, and research publications, to ...

The Patent Office has extensively and thoughtfully analyzed legal precedents it is required to follow and attempted to harmonize and synopsize those precedents. 3 Its guidance sets forth complicated ...

In Part 1 of this two-part series, I discussed strategies to ensure biocompatibility success from an organizational standpoint. In this second part, I will briefly discuss some of the ways to ensure ...

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 ...

Each clause contains the requirements as well as sub-clauses, which support the main clause by providing the details of the standard’s requirements for a QMS. For the purposes of this article, 21 CFR ...

Product labels that appear on device packages, admittedly, are not the most exciting part of medical device product design and development. They lack the excitement of scientific discovery, the cachet ...

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 — ...

European Medical Device regulations define “benefit-risk determination” as "the analysis of all assessments of benefit and risk of possible relevance for the use of the device for the intended purpose ...

Medical device developers are likely more than familiar with the terms “intended use” and “indications for use.” But not everyone understands exactly what they mean, how they are different, and how ...