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, ...

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.

The integration of environmental criteria into Latin American medical device procurement is not a temporary policy experiment ...

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

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 ...

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

An FDA warning letter is more than a formal notice; it’s a visible sign that a company’s quality system has failed to meet critical expectations. Yet behind every warning letter lies a wealth of ...

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 — ...