Iec 62304 specifically defines the maintenance and development of the medical device software mainly when

  • The software is used as a component, part, or an accessory of medical device.
  • And when software, itself is a medical device.
  • Apart from this the software is used in the production of a medical device too.

What Iec 62304 actually is

The standard actually covers safe design and maintenance of that software. It provides all the activities, processes as well tasks to ensure safety.

There are particularly nine parts of this safety standard which are as follows

  • Scope
  • Normative references
  • Definitions
  • General requirements
  • Software development process
  • Software maintenance process
  • Software risk management process
  • Software configuration management process
  • Software problem resolution process and all

Safety classification of IEC 62304 Software

It is much important to ensure the safety that is from the initial of development. It’s actually need to be tested even testing is not enough to ensure the safety of the patient, where patient safety is critical. Moreover, building safety into that particular process even early on saving time and expense it later.

Determines the safety

On the other part software safety classification in the standard that determines the safety related to the processes that you need to use. This impact is the overall software development cycle starting from the coding as well as requirements to maintenance and release.

Ensure a safety in the entire maintenance process

While using this software development tools it could help you to ensure a safety in the entire maintenance process. As an example, suppose there is a requirement to establish a software maintenance program. Then you can use such software, including Helix ALM, to document that planning.

The entire maintenance process

And managing change is the main key in this entire maintenance process. While using Helix ALM, which is gives you the accurate visibility into change all across the software development lifecycle. Even mainly while it paired with a version of control system, like Helix Core. And you could reduce this software maintenance by ensuring the code that is written over accordance to an established standard and also by measuring code quality. Helix QAC can do this on your behalf as well.

Why iec 62304 is compulsory?

It has been proved by (ANVISA) National Health Surveillance Agency that all medical devices must meet all the requirements of effectiveness as well as safety. And iec 62304 may be employed in this technical reports or technical dossiers. And it is currently not mandatory to be certified on that standard as well.

Similar Posts