IEC 62304 Compliance with Parasoft

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IEC62304

What is IEC 62304?

Used in the medical device industry, the IEC 62304 standard provides a framework for software lifecycle processes with activities and tasks necessary for the safe design and maintenance of medical device software. The US FDA accepts IEC 62304 compliance as evidence that medical device software has been designed according to the required regulations/standards, as it enforces traceability and repeatability of the development and maintenance process.

Enforcing IEC 62304 Compliance with Source Code Analysis, Unit Testing, Traceability, and More

The IEC 62304 standard introduces different measures to assure proper software design, implementation, and testing depending on the possible effects of the software failure on the patient. Parasoft users can leverage Parasoft C/C++test to reduce the cost of achieving IEC 62304 compliance by automating multiple testing methods required by the standard to save time and effort. 

IEC 62304 Compliance with Parasoft

IEC 62304 Safety Classes

As the standard states, "The MANUFACTURER shall assign to each SOFTWARE SYSTEM a software safety class (A, B, or C) according to the possible effects on the patient, operator, or other people resulting from a HAZARD (being a potential source of Harm) to which the SOFTWARE SYSTEM can contribute." Manufacturers are obliged to classify the system being built with one of the three safety classes for software safety levels, introduced by IEC 62304.

Class A

No injury or damage to health is possible.

Class B

Non-serious injury is possible.

Class C

Death or serious injury is possible.

How Parasoft Helps Achieve IEC 62304 Compliance

Parasoft users can leverage Parasoft C/C++test to reduce the cost of achieving IEC 62304 compliance by automating multiple testing methods required by the standard to save time and effort. Automatically-generated reports and dashboards provide teams with a practical way to prevent, expose, and correct errors in the software and prepare the documentation required for the audits.

Parasoft C/C++test facilitates and automates the software testing methods specified in IEC 62304, part 5 of which defines a set of processes and activities for the medical device software lifecycle, which are defined in the following chapters of the standard:

  • 5.1 Software development planning
  • 5.2 Software requirements analysis
  • 5.3 Software architectural design
  • 5.4 Software detailed design
  • 5.5 Software unit implementation and verification
  • 5.6 Software integration and integration testing
  • 5.7 Software system testing
  • 5.8 Software release

Achieving compliance with IEC 62304 requires building solid software development and testing processes that are supported with multiple tools. In case of verification and validation work, organizations need a solution that include multiple testing methodologies as there is no one single technique that can lead to compliance.

Mapping Parasoft Solutions to IEC 62304 Activities

Achieving compliance with IEC 62304 requires building solid software development and testing processes that are supported with multiple tools. Parasoft C/C++test is the only software development and testing solution on the market that includes a broad scope of testing methodologies to maximize efficiency and improve results. See more specific mappings below:

Chapter IEC 62304 Requirement Parasoft Support
5.2 Software Requirements Analysis Requirements Traceability Reporting
5.7.4 Software System test procedures trace to software requirements Requirements Traceability Reporting
5.6 Software integration and integration testing Integration Test Cases and Application Monitoring/Coverage Reporting
5.6.6 Conduct regression tests Unit Testing
5.5.2 Software unit verification Unit Testing
5.5.3, 5.5.4 Software unit acceptance criteria Static Analysis, Metrics, Flow Analysis
5.7.3 Retest after changes Test Impact Analysis
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Relevant Resource

Static Analysis for FDA Software Validation Compliance

The FDA has publicly recommended that software developers use static analysis for ensuring medical device software safety and reliability. Adopt static analysis as part of an integrated, comprehensive compliance process.