ANSI/AAMI HE75:2025—Medical Device Design
Medical devices are essential to modern healthcare, but their safety and effectiveness rely heavily on human factors engineering (HFE). HFE helps reduce use errors (a…
ISO/IEC 3532-1:2023—3D Printing in Medicine
3D printing technology has caused a revolution in health care delivery. It is being widely adopted for various applications, including anatomical modeling, surgical planning, the creation…
What’s New in the 2025 ASA/ANSI S3.6 Audiometer Standard?
According to the National Institute of Health (NIH), approximately 15% of American adults (37.5 million) aged 18 and over report some trouble hearing, about one…
How Horseshoe Crabs’ Blue Blood Keeps Medicine Safe
If you have received a vaccine, injection, or implant, you can thank the horseshoe crab (Limulus polyphemus) because chances are that medical procedure or product…
ASTM Standards for MRI Safety and Testing
MRI’s history traces back to the 1930s with Isidor Rabi’s discovery of nuclear magnetic resonance, which demonstrated that atoms could emit radio waves in a magnetic…
GMP for Pharmaceutical Excipients: NSF/IPEC/ANSI 363-2024:
What Are Pharmaceutical Excipients in NSF/IPEC/ANSI 363? Pharmaceutical excipients are essential to the safety, quality, and efficacy of drug products, as they impact a variety…
IEEE 2621.1-2022: Wireless Diabetes Device Security
A growing number of people with diabetes are turning to wireless diabetes devices to monitor and manage their condition in an automated fashion. As diabetes…
AAMI TIR109:2025—External Transport of Medical Devices
The U.S. healthcare transportation market was valued at $21.82 billion in 2017 and is projected to grow to $31.51 billion globally by 2026. This growth…
What Are GLP-1s and What Standards Do They Adhere to?
Although GLP-1 drugs have been around for years, they have recently been making headlines due to a rise in popularity as weight loss agents. Approximately…