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Inclusions This Technical Information Report (TIR) provides perspectives on the application of AGILE during medical device software development. It relates them to the following existing standards, regulations, and guidance: • ISO 13485:2003, Quality management systems─Requirements
This document provides the principles, concepts, terms and definitions for health software and health IT systems, key properties of safety, effectiveness and security, across the full life cycle, from concept to decommissioning, as represented in Figure 1. It also identifies the transition...
Due to progress in the development of communication systems, it is now possible to develop low-cost wearable communication systems. A wearable antenna is meant to be a part of the clothing or close to the body and used for communication purposes, which include tracking and navigation, mobile...
5.1 Information security programs and controls should be implemented by all cannabis businesses to protect information assets, which include information system infrastructure, architecture, analog (paper) and electronic data, files and records. 5.2 The cannabis industry is in transition from an...
1.1 This guide describes different mathematical methods that may be used to calculate absorbed dose and criteria for their selection. Absorbed-dose calculations can determine the effectiveness of the radiation process, estimate the absorbed-dose distribution in product, or supplement or complement,...
This document describes and defines the PROCESS of REFURBISHMENT of USED MEDICAL IMAGING EQUIPMENT and applies to the restoring of USED MEDICAL IMAGING EQUIPMENT to a condition of safety and performance comparable to that of new MEDICAL IMAGING EQUIPMENT i.e. MEDICAL...
This document specifies terminology, principles and a process for risk management of medical devices, including software as a medical device and in vitro diagnostic medical devices. The process described in this document intends to assist manufacturers of medical...
Imaging modalities in radiology produce ever-increasing amounts of data which need to be displayed, optimized, analyzed and archived: a "big data" as well as an "image processing" problem. Computer programming skills are rarely emphasized during the education and training of medical...
