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 ...

Visit Medbio at Booth #941, November 19–20, to explore custom injection molding and assembly solutions, supporting Class I–III devices with quality, compliance, and MedTech innovation.

Current risk analysis methods focus on the possibility and severity of bad events instead of focusing directly on analyzing and improving the performance of systems and processes producing the bad ...

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 ...

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 ...

This short review serves as an introduction to the utility of polymeric materials employed in healthcare and medical devices (MD). Some terminology and nomenclature used to commonly describe polymers ...