Risk Management
As part of its effort to address the changing landscape around artificial intelligence (AI) in medical devices, the U.S. Food and Drug Administration (FDA) has recently released two new guidance documents on artificial intelligence-enabled device software functions (AI-DSF):
• “AI-enabled…
On April 8, 2025, a driverless Zoox robotaxi misjudged an approaching vehicle, braked too late, and sideswiped it at 43 mph on the Las Vegas Strip.
One month later, the Amazon subsidiary issued a software recall on 270 autonomous vehicles and suspended operations while regulators…
Anyone who has cracked their smartphone screen or had a rapid oil change knows that sometimes the OEM isn’t the most affordable or convenient service option. Consumer flexibility, paired with lower-cost, high-quality options, is logical, whether it’s in the consumer market or in healthcare.…
This past weekend I engaged in one of my favorite activities as a beekeeper. I got to catch a swarm of bees.
If you haven’t seen it before, it’s wild. About half of the bees leave with a queen and set up somewhere temporarily while they’re looking for their new permanent home. In…
According to the U.S. News & World Report article “FDA Warns Sanofi of Manufacturing Irregularities at Key Facility” (Jan. 23, 2025), the pharmaceutical company Sanofi received a U.S. Food and Drug Administration warning letter “stating that FDA inspectors found irregularities with the…
The cornerstone of efficient industrial and facility management, maintenance, repair, and operations (MRO) cover all activities related to equipment maintenance, procurement, upkeep, and inventory management. This includes spare parts, consumables, lubricants, cleaning supplies, safety equipment…
