Understanding the crucial overlaps between FDA disclosures and patent law is important for medical device innovators seeking ...

This in-depth article describes risk in cleaning and provides a science- and risk-based framework for selecting analytical methods using ASTM International standards. Here are practical tips to build ...

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

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 ...

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, ...

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 ...

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 ...

Discover Accumold’s micro molding expertise at COMPAMED 2025, where ultra-precision, scalability, and DfMM capabilities showcase how next-generation medical devices are enabled through unmatched ...

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 — ...

Having a common understanding of the functional utility for each stage of prototype development is essential to managing the expectations for everyone involved in a project, from the designers to the ...

A common dilemma for early stage medical device companies is their lack of expertise in medical device development. As expected, the development team is busy establishing the company itself while ...

The medical device market is diverse, fast-moving, and powered by dynamic customer needs and ongoing demand. Anticipated to reach $734.39 billion by 2027, the market is a land of both opportunity and ...