Purpose

This paper reviews the implementation of the ANSI/AAMI/IEC 62304 Medical Device Software – Software Life Cycle Processes standard. This paper has two objectives:

1. To provide an overview of the dynamic utilization of ANSI/AAMI/IEC 62304 with regards to key concepts and activities. Illustrated in this document is the relationship between Processes, Activities and Tasks of the various software classes.
2. To give pointers to the various clauses of this Technical paper that provide guidance to a user for applying the standard concepts, processes, activities, and tasks.

Audience

This Technical paper is applicable to audiences as identified below:

1. Those who implement the Standard
2. Those who use the Standard for a specific system
3. Those who prepare Organisational Quality Management Systems based on the international standards.

Prerequisites

The list below provides prerequisites for the users of the Technical Paper:

1. Availability of ANSI/AAMI/IEC 62304
2. Familiarity with ANSI/AAMI/IEC 62304
3. General Knowledge of project management, systems development processes and system life cycle models.

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