Search results
13 maj 2019 · One revolutionary development in digital health technology is software that can perform complex medical functions—software as a medical device (SaMD). SaMD can diagnose conditions, suggest treatments, and inform clinical management.
8 lut 2024 · The purpose of the IEC 82304-1 standard is to identify product requirements for health software manufacturers, such as requirements on: Risk management; Product validation; Installation instructions; Instructions for use; Most medical devices need to meet more than one standard.
2 sie 2016 · It defines an encoder as a device, circuit, transducer, software, algorithm, or person that converts information from one format to another. It provides examples of linear encoders that encode position and digital encoders that convert multiple inputs into a binary coded output.
13 gru 2018 · When it comes to medical devices, best practices for software interface design are not an option. They're an absolute necessity. This truth has been recognized by international standards organizations, successful medical device manufacturers, and key regulatory bodies, including the Food and Drug Administration.
25 sty 2024 · Here are a few examples of medical device software: Pacemaker programming software (likely an accessory to pacemaker software, can be SiMD or SaMD) Insulin pump control software (typically SiMD or embedded software) Diagnostic imaging software (likely SaMD software using images from other medical devices)
26 sie 2024 · Discover how Software as a Medical Device (SaMD) is revolutionizing healthcare. Learn about its benefits, regulatory requirements, and integration strategies to enhance patient outcomes and compliance.
Software as a medical device is defined as “software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.” “Medical purposes” may include diagnosis, prevention, monitoring, treatment or alleviation of disease
