AAMI CR515:2025—Cybersecurity in ML Medical Devices
While medical devices are designed to heal, monitor, or save lives, they could instead become a tool for harm if compromised. The healthcare sector is…
ISO 10993-1:2025—Biological Evaluation of Medical Devices
Medical devices range from simple bandages to complex implantable devices like pacemakers and prosthetics. Regardless of their complexity, all medical devices must undergo rigorous testing…
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…
Quality Credentials in Emergency Medical Services: Safeguarding the Public Through Certification
When disasters strike, emergency medical services (EMS) clinicians are among the first to respond. Whether stabilizing a patient at the scene of an accident or…
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…
ISO/IEEE 11073-10410: 2019— Insulin Pump
Insulin pumps can be recommended for people with diabetes who have trouble managing their blood sugar levels or who have a lifestyle that makes it difficult…
ISO 15197:2013 — Blood-Glucose Monitoring Systems
In vitro means “in glass.” As such, in vitro diagnostics are tests usually conducted in test tubes and similar instruments. In vitro diagnostics (IVD) can…
Diabetes Treatment and Care Standards
38.4 million people have been diagnosed with diabetes in the United States. The number of people diagnosed with diabetes in the U.S. has increased in recent…