ISO 10377:2013— Consumer Product Safety
According to the Consumer Product Safety Commission (CPSC), in 2020, an estimated 28.5 million people sought medical attention for consumer product-related injuries in the United States,…
INCITS/ISO/IEC 27102:2019 (2020)–Cyber-Insurance
In the first half of 2024, the frequency and value of large cyber insurance claims increased by 14% and 17%, respectively, compared to 2023; according…
ANS/ASME RA-S-1.1-2022: Probabilistic Risk Assessment
Probabilistic risk assessment (PRA) originated in the aerospace industry during and before the Apollo space program: the U.S. space project of the 1960s and 70s…
How Does Accreditation Save Your Organization Money?
Accreditation (i.e., the process of evaluating an institution or program to assure it meets certain standards) goes hand in hand with lower costs. This process…
IEC 62061 Ed. 2.0 b:2021—Safety Of Machinery
The automated control system is now considered a vital part of the infrastructure that helps ensure the smooth running of plants, pumping stations, utilities, and…
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…
ISO 14971:2019–Risk Management To Medical Devices
Flint knives, saws, and drills were used for surgery, amputation, and trepanation during the Upper Paleolithic and Mesolithic times in 6000 BCE. These were the…
ANSI/AAMI SW96:2023—Medical Device Security
The steps that involve manufacturing, regulation, planning, assessment, acquisition, and management of medical devices are complex but essential to guarantee their quality, safety, and compatibility…