If devices are integral to positive patient outcomes, device partners must play an integral role to ensure regulatory ...

Biocompatibility assessment per ISO 10993 ensures medical device safety by evaluating materials, risks, and biological ...

Needles and syringes are commonly used to retrieve cell therapies from vials, posing the risk of needle stick injury. Explore ...

Enhancing catheter visibility under fluoroscopy, custom radiopaque filler blends improve imaging clarity without compromising ...

Thermoplastics revolutionized medical technology by replacing glass with flexible PVC. Learn how their versatility supports advanced healthcare applications, from wound care to life-saving devices.

<p>Polyzen is an innovative leader in the manufacturing and processing of components for a wide range of medical devices and is a preferred supplier to medical device OEMs worldwide. Extensive ...

Prototype development and product concept optimization is a core expertise for Polyzen. We have nearly three decades of experience developing and optimizing a wide variety of polymer-based medical ...

The digital revolution that resulted in the IoT, IoMT, SaMD, and connected devices comes with the possibility of cyberattacks. The FDAs latest efforts to enhance medical device cybersecurity include a ...

As the medical device industry continues to expand, intellectual property (IP) considerations — especially those concerning patents — are critical for medical device innovators and manufacturers.

Polymer physics and mechanical engineering principles contribute significantly to the advancement of percutaneous transluminal coronary angioplasty (PTCA) and balloon catheter expansion. This article ...

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 — ...