The medical device industry has gone global, but most quality and regulatory leaders still operate with regional mindsets. Leaders who master cultural intelligence build quality systems that leverage ...

Probability of harm (POH) is critical to appropriately scoring risks, so how should it be done? POH needs to show all probabilities, not suppress them.

Learn more about the critical tests for ensuring the proper performance of auto-injectors, which are used for a variety of ...

Cleanroom micro molding ensures ultra-small components meet strict contamination and performance standards. As devices shrink ...

Liquid Silicone Rubber (LSR) is redefining optical micro molding with superior durability, design flexibility, and thermal ...

Establishing combination product shelf life requires aligning stability. Holistic, data-driven stability studies ensure ...

Ready to improve your submission success rate? Define clear submission goals, ensure cross-functional collaboration, and ...

Connected medical devices must treat Protected Health Information (PHI) protection as integral to patient safety and compliance. Understand the data flows and HIPAA requirements to design security.

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 ...

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