ANSI/AAMI/ISO 23500-2:2024—Hemodialysis Water Treatment
Healthy kidneys continuously filter waste products, excess fluids, and toxins from the bloodstream. When kidneys fail, hemodialysis (i.e., a life-saving treatment for kidney failure) performs…
ISO 10993-6:2026 — Implantation Effects Testing
When a medical device is implanted into the human body (whether temporarily or permanently) it triggers a biological response. The difference between safe integration and…
ISO 14155:2026— Clinical Investigation of Medical Devices
Bringing a medical device to market is not just about innovation; it is about trust. Before a device ever reaches a patient, it must undergo…
Minimizing Micro-Mistakes in Medical Manufacturing: A Closer Look
In medical manufacturing, even the smallest deviation is more than a cosmetic issue. It represents real risk. A micron of excess material, a slightly rough…
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 11608-1:2022—Needle-Based Injection Systems
Needle-based injection systems (NISs) are extremely common and represent the primary method for drug delivery, with at least 16 billion NISs injections administered globally each year. Therefore,…
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…
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…