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 ...

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

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

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 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 ...

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 ...

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