Probability of harm (POH) is critical to appropriately scoring risks, so how should it be done? POH needs to show all probabilities, not suppress them.

Establishing combination product shelf life requires aligning stability. Holistic, data-driven stability studies ensure ...

Learn more about the critical tests for ensuring the proper performance of auto-injectors, which are used for a variety of ...

Cleanroom micro molding ensures ultra-small components meet strict contamination and performance standards. As devices shrink ...

Ready to improve your submission success rate? Define clear submission goals, ensure cross-functional collaboration, and ...

Liquid Silicone Rubber (LSR) is redefining optical micro molding with superior durability, design flexibility, and thermal ...

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 ...

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 ...

A new concept in ampoule packaging, molded entirely of plastic and safe for unlimited consumer use, is available from James Alexander Corporation under the brand name plastiqueAmp A new concept in ...

In recent years, the digitalization of the healthcare industry has been accelerated to meet demands for smarter devices and robotics, wearable technology, AI-based data analysis, and enhanced ...

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 — ...