The project will create at least 200 new, full-time jobs over the next three years and retain 1,704 existing full-time positions. The Commonwealth is supporting the project with $1.5 million in state ...

Discover how digitized workflows and real-time verification are helping streamline clinical trial packaging, reduce ...

New regulations challenged how surgical kits were tracked and processed across 15 U.S. sites. Discover how one team balanced compliance and efficiency to keep life-saving procedures on schedule.

Current risk analysis methods focus on the possibility and severity of bad events instead of focusing directly on analyzing ...

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

Accumold will showcase its precision micro molding expertise at MEDevice Boston 2025, Booth 815, highlighting early design collaboration that accelerates innovation for next-generation medical devices ...

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 ...

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

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 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 ...