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 ...

Qualification, and demonstration of fit-for-purpose, for a drug product vial/stopper/seal primary package system comprises many factors: protection, compatibility, safety, and performance. One of the ...

DSM Biomedical offers Medeor® Matrix Surgical Mesh with extracellular biologic for the reinforcement of soft tissue during the healing process. This non-crosslinked biologic mesh is ready to use right ...

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 ...

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 ...

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 — ...

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 ...

In the previous article, “How The Right Operating Model For EU MDR Compliance Can Support A Global Footprint,” we discussed key factors for maintaining operational excellence to achieve cost reduction ...

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 ...

This is the second in a series of articles on the changes in the medical device risk management standard ISO 14971 that were released in December of 2019 and supported by guidance in the ISO TR ...