Software Configuration Management Medical Device

 

IEC 62304 is an essential standard if you are working with the development of medical device software. In this article, you will get an overview of the scope of this standard, along with the configuration management process which will help you keep track of information, changes, and source code.

IEC 62304 is a process standard with a list of requirements and activities you should carry out throughout your development cycle. There are no requirements in the standard forcing you to apply a specific development method. You can use whatever method you want if you acknowledge the process approach and perform the required activities in the standard.

Some key elements in the standard are development, risk management, configuration management, problem resolution, and maintenance. Each of the processes is divided into activities where the development process has the most activities.

A software project usually has more configurations items to control then all documents together in a full development project. If you look at the definition of a configuration item, it says, “entity that can be uniquely identified at a given reference point”.

In the software domain, a given reference point can be down to hours even minutes. This is very different if you compare with documents that are typically released with the help of signatures and at a much slower pace.

IZiel has highly trained configuration managers who will be able to create, coordinate and implement the Configuration Management Plan (CMP – includes responsibilities and resources, (including personnel), training requirements, administrative meeting guidelines (including a definition of procedures and tools), baselining processes, configuration control and configuration-status accounting, naming conventions, audits and reviews, subcontractor / vendor configuration management requirements, regulatory requirements) for Product Creation Process (PCP) projects in co-operation with the Project Managers and Operations Department.

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