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 15223-1:2021—Medical Devices Symbols
Symbols on medical devices are crucial for patient safety, regulatory compliance, and effective communication, allowing for clear and concise information across different languages and cultures. ISO…
AAMI 80001-GS:2011— Getting Started With IEC 80001
Medical errors occur far too frequently: over 7 million American patients are impacted by medical errors each year; there are 7,000 to 9,000 Americans who…
AAMI TIR12:2020 (R2023)— A Guide for Device Manufacturers
Medical device manufacturers are required to design and build quality into their products. This means that they must have processes and procedures in place to ensure…