This article describes causal mechanism and effect analysis (CMEA) as an alternative to failure mode and effect analysis ...

Drawing on insights from the global regulatory landscape, industry trends, and direct feedback from customers, Dr. Di Wu ...

Simplify the complexity of combination product development by partnering for integrated support across device design, ...

Let's take a closer look at the current electronic quality management system (eQMS) landscape in pharma/biotech and what a future-ready eQMS must enable to support continuous improvement. A case study ...

Ethylene oxide (EO) remains a foundational sterilization method for nearly half of all medical devices, particularly those with complex geometries or heat-sensitive materials. However, the industry is ...

The FDA’s traditional classification system effectively labels a medical device’s clinical risk, but it is a poor predictor of how easily that same device can be hacked. While a Class III implantable ...

Low-code MES promises speed, but agility comes from ownership. Composable, no-code approaches give operations teams the ...

As syringe-based products evolve toward higher viscosities and larger fill volumes, longstanding assumptions about dye ingress testing face growing mechanical constraints. Earlier analysis showed that ...

Traditional MES platforms were built for stable environments that no longer exist. Manufacturers are now adopting composable ...

Build regulatory strategy into your company from day one — not as support, but as a core driver of value, risk management, ...

Autoinjectors bring a level of complexity to pharmaceutical manufacturing that goes far beyond traditional parenteral presentations. By pairing a sterile drug container with a mechanical delivery ...

Low-pressure balloons support fixation and device delivery by conforming to complex vascular anatomy. Material choice and manufacturing method play a defining role in compliance and durability.