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

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

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

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

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

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

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.

Complex vascular procedures demand more from delivery systems. Learn how sheath design, materials, and surface performance influence navigation, vessel protection, and device deployment.

As orthopedic and minimally invasive procedures grow more complex, surgeons increasingly rely on visual cues to manage sutures accurately and efficiently. Color in medical textiles has evolved from a ...

Raising funds in the medical device industry is always challenging. Doing so as a startup can be even more so. And U.S. medical device companies seeking funding this year will find that innovative ...

Within the EU's regulations, Article 10(9) refers to quality system requirements under Annex IX. This is a specific requirement concerning quality control for the devices that use AI technology under ...

Eli Lilly and Company's one-team mindset aims to templatize facility design while remaining nimble enough to react to new manufacturing breakthroughs. Many manufacturing execution system (MES) ...