Discover how digitized workflows and real-time verification are helping streamline clinical trial packaging, reduce complexity, and improve quality in a high-stakes, time-sensitive environment.

New regulations challenged how surgical kits were tracked and processed across 15 U.S. sites. Discover how one team balanced ...

Rapid prototyping has taken the medical device industry by storm, but there are pros and cons that device developers need to ...

Whether youre refining existing protocols or developing new ones, this guide serves as a valuable resource for ensuring safe, ...

PolyPeel™ peelable polyester heat shrink tubing streamlines catheter manufacturing with speed, precision, and sustainability, offering a PFAS-free alternative to FEP for safer, more efficient medical ...

In the pharma/biotech and medical device industries, the audit trail is important to have for accountability, data integrity, repeatability to create an event for investigation, and regulatory ...

Medical device manufacturers must maintain a detailed Device History Record (DHR) to meet FDA requirements and ensure ...

Autoinjectors revolutionized drug delivery, but innovation is shifting toward oral, wearable, and alternative platforms.

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 ...

Sterilization validation is vital in medical device manufacturing to ensure products are free from viable microorganisms and safe for patient use. It confirms that devices meet sterility assurance ...

The U.S. Food and Drug Administration (FDA) has issued its much-anticipated final guidance on cybersecurity risk management in medical devices, effective June 2025. This document, titled ...

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