IEC 62304 Is Effective And Safe Medical Device Software

‘Requirement Management Tool’ the word itself contributes to the meaning in its truest form. With the advent of technology and various services there are countless options to choose form. That is where the importance of Requirement Management Tool comes. Due to the availability of multiple options in market, confusion arises.

Requirement Management Tool

To solve these types of problems we need Requirement Management Tool. This is basically software which can give you the best result or product as per your need. To build a medical device the manufacturers have to ensure the safety and effectiveness of the medical device containing software. In that case iec 62304 the international standard that ensures all of them.

Why do we require Requirement management tool?

  1. The quality of a product is measured by how it fulfils your need or requirement. To decide its potential we need this kind of software.
  2. It helps in record based management of requirements and also in document based requirement.
  3. It can automatically generate documents.
  4. This type of software can easily create simulations and automatically generate tests.
  5. It can easily manage changing requirements.

What is IEC 62304?

International Electro technical Commission is an international standards organization that prepares and publishes the international standards for manufacturing of medical device software and the development of that very software. IEC 62304 is one of them. This standard is certified by both the United States and the European Union. In case of European Union, if the medical device manufacturer comply with the IEC 62304 then it satisfy the requirements contained in Medical Devices Directive 93/42/EEC (MDD) with amendment M5 (2007/47/EC) as related to software development.

How does IEC 62304 woks?

According to IEC 62304, medical device manufacturers should strive to implement a risk-based, structured, and methodical approach to medical device software development and ensure traceability throughout the lifecycle of medical device software to achieve compliance with the standard. For the implication of IEC 62304 software, there are several stages as follows:

  • Software Development Process
  • Software Maintenance Process
  • Software Risk Management Process
  • Software configuration management process
  • Software Problem Resolution Process

What are the safety classes?

The manufacturers of medical devices must assign a safety class of the software system as a whole to get certified by IEC 62304. There are three safety classes described below:

Class A – the software can not cause any harm

Class B – the software can cause minor harm

Class C – the software can cause major harm.