This article addresses everything that follows the signed contract for an eQMS: how a system is configured, validated, ...

Nordson MEDICAL introduces Divert™ ULTRA, ultra-high-pressure stopcocks engineered for reliable flow control, ergonomic operation, and precision in demanding medical applications up to 1,500 psi.

Standard extraction protocols routinely fail tissue-derived products, hydrogels, absorbables, and silicone implants. Learn ...

The computer system validation playbook was written for software that holds its shape. AI doesn't. Validating it has to become an act of governance. Micro insert molding enables smaller, more ...

Learn how causal mechanism and effect analysis (CMEA) and its principles can be used to develop and maintain safer working environments in the pharma/biotech and medical device industries. Medical ...

Patient-centric design is essential in wearable medical devices, where comfort, accuracy, and reliability directly impact user adherence and clinical outcomes. Designers face the challenge of creating ...

If your devices are sterilized with ethylene oxide (EtO), ISO 10993-7:2026 changes how you justify your residual acceptance criteria, and the shift is more substantive than a simple limit update.

The majority of IV infusions are performed in acute care settings, such as hospitals and other out-patient centers. 1 Infusion of medication is a common form of treatment in hospitals across the ...

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 ...

In 2023, the FDA made the electronic Submission Template And Resource (eSTAR) mandatory for most 510(k) submissions. Although eSTAR is not an AI tool, the move was the first definitive leap toward the ...

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 ...

FDA has now completed just over 100 inspections under its new Quality Management System Regulation, and the agency has begun sharing preliminary observations from those inspections. Early FDA findings ...