This paper reviews the implementation of the ANSI/AAMI/IEC 62304 Medical Device Software – Software Life Cycle Processes standard. This paper has two objectives:
- 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.
- 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.
This Technical paper is applicable to audiences as identified below:
- Those who implement the Standard
- Those who use the Standard for a specific system
- Those who prepare Organisational Quality Management Systems based on the international standards.
The list below provides prerequisites for the users of the Technical Paper:
- Availability of ANSI/AAMI/IEC 62304
- Familiarity with ANSI/AAMI/IEC 62304
- General Knowledge of project management, systems development processes and system life cycle models.
You can download the White Paper here