Medical and Healthcare

In medical devices software plays a significant role and software quality and risk management are essential in order to develop safe software. Medical devices are expected to be developed with good engineering practices and all companies active in the medical device market must ensure the highest quality of software development.
The IEC/ISO 62304 standard defines a risk and quality driven software development process for the development of medical devices. IEC/ISO 62304 indicates the need for rigorous testing, acceptance criteria, and traceability. Performing this requirements without suitable tools is impossible.
Software testing tools including dynamic analysis, code coverage, and static analysis tools, are part of good software engineering practice and help medical device manufacturers achieve safe and reliable software.
The ability to support and enhance testing and acceptance processes and the analysis of SOUP (Software of unknown/uncertain pedigree/provenance), means better quality, safety, and security for medical software.

Meet the Code Coverage Requirements for Medical Devices with Testwell CTC++ Code Coverage Analyzer

Good quality of your software development can not be achieved without dynamic code analysis. When doing dynamic analysis it is important to make sure that all parts of safety and/or security critical code are tested.
Although code coverage is not mandatory according to IEC 62304 (Version 1.1), the standard recommends in the non-normative section, that you increase the code coverage.
The "Guidance Document" of the U.S. Food and Drug Administration (FDA) states: "Measures such as […] testing coverage […] are all used to develop an acceptable level of confidence before shipping the product. […] [Decision Coverage] is considered to be a minimum level of coverage for most software products, but decision coverage alone is insufficient for high-integrity applications."
Testwell CTC++ Code Coverage Analyzer makes the analysis of the Code Coverage easy. The tool shows all code coverage levels required by the FDA. The outputs of Testwell CTC++ can be stored in text or XML formats and transformed in clear and easy to understand HTML or JSON reports.
Testwell CTC++ shows Statement Coverage, Decision/Condition Coverage, Modified Condition Decision Structural Coverage (MC/DC) and even Multiple Condition Coverage.
Testwell CTC++ has a very low instrumentation overhead. It can be used with all compilers and all embedded targets - even for very small ones.
Testwell CTC++ maked code coverage an easy activity.
The tool is widely used in safety critical projects. The Tool Qualification Kit for Testwell CTC++ makes the qualification of Testwell CTC++ within your projects easy and helps to certify your products.
Learn more about Testwell CTC++

Static Analysis

Section 5.5.2 of IEC 62304 requires a software unit verification process:
The MANUFACTURER shall establish strategies, methods and procedures for verifying each SOFTWARE UNIT.

Section 5.5.3 requires:
The MANUFACTURER shall establish acceptance criteria for SOFTWARE UNITS prior to integration into larger SOFTWARE ITEMS as appropriate, and ensure that SOFTWARE UNITS meet acceptance criteria ... does the software code conform to programming procedures or coding standards?

Section 5.5.4 provides additional software unit acceptance criteria including

• proper event sequence;
• data and control flow;
• planned resource allocation;
• fault handling (error definition, isolation, and recovery);
• initialisation of variables;
• self-diagnostics;
• memory management and memory overflows; and
• boundary conditions.

Many of these acceptance criteria are well suited to static code analysis.

The FDA recommends for all companies developing software for medical devices the use static code analysis in the Software Development Life Cycle (SDLC) to ensure safe and reliable software. In fact, static code analysis tools are excellent to detect and fix bugs. Because the analysis is performed early in the implementation phase, static code analysis brings significant cost reduction potential.

Seminars

Developers and managers of safety critical software need best knowledge in order to provide excellent software.
Verifysoft supports you with seminars and workshops.

Hundreds of Companies and Organisations enhance their Software Quality with Verifysoft's Testing Solutions

Verifysoft's Testing solutions have proven success in safety and security critical software development within the medical sector. Our satisfied customers include: