Why To Implement Iec 62304


In a software development there are few steps that define the entire process accordingly. Just like starting from

  • Development planning
  • Detailed analysis as per requirements
  • The architectural design
  • A detailed design
  • Unit implementation and verification
  • Integration and integration testing
  • The entire system testing
  • And at last release

Proper development of the medical software

The standard iec 62304 defines the requirements for a life-cycle for a proper development of the medical software and also for the software within its medical devices. And it applies to the maintenance as well as development of medical device software while the software itself is a medical device or when the software is an integral or embedded part of the final medical device as well.

Software for the medical industry

These days software becomes more and more important one for the medical industry. As we know it is used in a medical device, as a medical device itself, for diagnostic purposes and for some other reasons. And also a certain number of devices could not function without appropriate software. But it is an important part that

How medical software get regulated and the impact on risk management

In that case you need to have a general overview on the regulatory framework for medical software, and the entire classification process of software and how this software works every day medical life each day. Actually there are few certain functions that classify the software as medical software and also as a medical device:

  • Calculation of anatomical data
  • Control of other medical devices
  • Diagnostic functions
  • Programming of medical devices
  • Evaluation of ECGs
  • Evaluation of medical risks
  • Control of active implants etc.

Image processing for diagnostic purposes

Iec 62304 the device that has been created to prevent the risk on medical sector.When  the risk has been reduced to an acceptable level by applying hardware related risk control measures, then accordingly it is possible to adjust the safety class. The safety class for each software system should always be documented in the risk of management file. Until a safety class has been assigned, the requirements still apply to each software system.

The conclusion

Implementation of iec 62304 is itself a positive attitude towards the medical device software that is acceptable in a positive way. It is international standard medical device software. It is a complete design that defines safety. Specifically EC 62304 defines three of the safety classes for software. One of them is which defines

Class A: no design documentation and poor testing,

Class B: design testing and documentation.

Class C: deep design documentation and testing as well.