Structural heart innovation demands thinner, stronger materials and scalable manufacturing. Read how material expertise and customization are overcoming industry challenges for better patient outcomes ...

Discover from Leibowitz Law how to embed compliance and contractual protections into your wearable device contracts from the outset.

MedTech accelerates innovation through acquisition and integration while pharma sustains research depth by distributing risk ...

Strategic, early testing is essential for ophthalmic device safety, performance, and compliance. Implementing parallel ...

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 ...

Accumold secures ISO 13485 recertification, reinforcing its commitment to precision, quality, and reliability in micro molded components for demanding medical device applications worldwide.

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 ...

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 ...

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 — ...