Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

Defines the life cycle requirements for medical device software. The set of processes, activities, and tasks described in this standard establishes a common framework for medical device software life cycle processes. Applies to the development and maintenance of medical device software when software is itself a medical device or when software is an embedded or integral part of the final medical device. This standard does not cover validation and final release of the medical device, even when the medical device consists entirely of software.

This European Technical Specification will provide a set of requirements for developers of health and wellness apps, intending to meet the needs of health care professionals, patients, carers and the wider public. It will include a set of quality criteria and cover the app project life cycle, through the development, testing, releasing and updating of an app, including native, hybrid and web based apps, those apps associated with wearable, ambient and other health equipment and apps that are linked to other apps. It will also address fitness for purpose and the monitoring of usage. The specification will inform the development of health and wellness apps irrespective of whether they are placed in the market, and including free of charge. The specification will not cover the processes or criteria that an app developer or publisher follow to establish whether a health and wellness app is subject to regulatory control (e.g. as a medical device, or related to information governance).

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 devices to identify the hazards associated with the medical device, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls. The requirements of this document are applicable to all phases of the life cycle of a medical device. The process described in this document applies to risks associated with a medical device, such as risks related to biocompatibility, data and systems security, electricity, moving parts, radiation, and usability. The process described in this document can also be applied to products that are not necessarily medical devices in some jurisdictions and can also be used by others involved in the medical device life cycle.

This document defines the core data set for a patient summary document that supports continuity of care for a person and coordination of their healthcare. It is specifically aimed at supporting the use case’ scenario for ‘unplanned, cross border care’ and is intended to be an international patient summary (IPS). Whilst the data set is minimal and non-exhaustive, it provides a robust, well-defined core set of data items. The tight focus on this use case also enables the IPS to be used in planned care. This means that both unplanned and planned care can be supported by this data set within local and national contexts, thereby increasing its utility and value. It uses the European Guideline from the eHN as the initial source for the patient summary requirements, then takes into consideration other international patient summary projects to provide an interoperable data set specification that has global application. This document provides an abstract definition of a Patient Summary from which derived models are implementable. Due to its nature therefore, readers should be aware that the compliance with this document does not imply automatic technical interoperability; this result, enabled by this document, can be reached with the conformity to standards indicated in the associated technical specification and implementation guides. This document does not cover the workflow processes of data entry, data collection, data summarization, subsequent data presentation, assimilation, or aggregation. Furthermore, this document does not cover the summarization act itself, i.e. the intelligence/skill/competence that results in the data summarization workflow.