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 ...

Managing global PFAS regulations demands a proactive strategy. Identifying and mitigating both intentional and unintentional sources is key to compliance and ensuring long-term product safety.

Vascular devices face mounting design and manufacturing challenges. Explore how hybrid material strategies and integrated expertise are helping developers balance performance, scalability, and ...

Connected medical devices must treat Protected Health Information (PHI) protection as integral to patient safety and compliance. Understand the data flows and HIPAA requirements to design security.