ISO 10993-7:2026 replaces table-based EO residual limits with a risk-based framework that requires manufacturers to justify ...

The European Commissions simplification package is being debated almost entirely as an MDR story. The IVDR provisions carry ...

The rapid emergence of artificial intelligence in life sciences compliance presents quality leaders with a dual operational challenge: avoiding adoption inertia while managing regulatory risk.

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 ...

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 ...

SCS devices deliver electrical pulses to the spinal cord to relieve chronic pain. They are often used as treatment for failed back surgery syndrome, injuries to the spinal cord, complex regional pain ...

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 ...

The evaluation of biological safety is one important piece of the puzzle to demonstrate the safety of a medical device. Commonly, manufacturers make use of the ISO 10993 series of standards to assess ...

Device functionality testing is an essential element of any medical device or drug delivery device development process. It is an essential part of design verification that demonstrates the developed ...

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 — ...

Zimmer Biomet is entering the burgeoning surgical robotics market through the acquisition of French company Medtech SA, developer and maker of the ROSA robotic device for neurological and spine ...