Shulou(Shulou.com)06/03 Report--

Inomed is an international medical technology company that develops neuroprotective devices and systems for precisely locating patients for treatment. Because the software that drives these innovative devices has no room for error, Inomed has established a wide range of processes to ensure the integrity of the software. This lifecycle quality process is critical to compliance with IEC 62304, the "coordinated" medical device software security standard adopted by the European Union and the United States.

In this article, we will discuss how Inomed can quickly automate established processes and introduce complete requirements traceability. This greatly reduces the amount of work required to achieve and maintain mandatory IEC 62304 certification.

Challenge: simplifying medical device software certification

Inomed has worked with doctors and users to develop new tools and methods in the areas of intraoperative neuromonitoring, neurosurgery, pain treatment and nervous system diagnosis. Inomed provides high-quality products to improve treatment effectiveness and uses innovative technologies to ensure the safety of treatment providers and patients.

J ö rgWipfler, head of development at Inomed, explained: "our products are used during surgery. If there is any failure during the operation, the operation may have to be terminated. In addition, because we monitor nerves and their signals, the wrong interpretation and decision software we make can cause users to make the wrong decisions. And may cause patients to be injured."

Because security is critical to medical devices, IEC has recently played an active role in standardizing software developed for medical devices used in Europe. The IEC 62304 standard provides a framework for the software lifecycle process, which includes the activities and tasks necessary for the secure design and maintenance of medical device software. It enforces traceability and repeatability of the development and maintenance process. FDA of the United States accepts IEC 62304 compliance as evidence that medical device software is designed as an acceptable standard.

After establishing most of the manual processes to achieve its initial IEC certification, Inomed wants to automate the risk management process. Their ultimate goal is to reduce the work involved in maintaining existing certifications and simplify their emerging and innovative certification processes.

Solution: automate the risk management process

Inomed decided that in order to simplify the risk management process, they needed an integrated system to cover application life cycle management (ALM) and standard C + + and .NET language code testing requirements. After investigating the market, they found that Parasoft was well suited to their needs.

Parasoft works with Inomed to integrate medical device compliance solutions, including Parasoft Concerto and Parasoft Test (using Parasoft C++test and Parasoft dotTEST).

Wipfler said: "the results of C++test and dotTEST can be used in Concerto. And the planned activities of Concerto can be transferred directly to our development environment." Parasoft's extensive support environment enables Parasoft solutions to be easily and quickly integrated into Inomed's heterogeneous development environments, including Visual Studio, Keil μ Vision, Bugzilla and CVS.

In addition, the solution further initiates the adoption process by deploying fully preconfigured virtual machines to Inomed. Immediately after delivery, Inomed can start using the system to validate their software and manage their processes.

Result: increased efficiency through automation

The Parasoft Test component of the solution allows Inomed to use standardized processes for static analysis, code review, and unit testing across C + +, C # and C + / CLI code. Wipfler attaches great importance to the value of having integrated and comprehensive solutions, he explains. "We now have a solution to automate unit tests using the same tools in different development environments and programming languages. In addition, the use of test products [dotTEST and C++test] is very simple. A predefined set of test rules for automated applications is very useful."

The Parasoft Concerto component of the solution is used to manage projects and document processes. It also associates requirements with automated and manual tests, source code, and development / test tasks. The current verification level of each requirement or task (including task pass / fail status and coverage) can be evaluated at any time by going back to all relevant tests. This complete requirement traceability is critical to IEC compliance.

"We completed [compliance with IEC 62304] before using the Parasoft tool," Wipfler said. "but our previous approach was paper-based and time-consuming. Using the new solution can significantly improve our efficiency because many manual steps can be automated."

After Parasoft's solution is integrated into Inomed's development process, the process is certified by DQS auditors against IEC 62304. "We can prove to our auditors that we have absolute traceability from every requirement or task to the source code, and we can be sure that all the work is our verification," Wipfler commented. "having automatically generated traceability is a huge advantage."

Why choose Para ​​ soft?

In summary, Wipfler cited the following reasons for choosing Para ​​ soft:

Easy to adopt with minimal learning curve

Seamless integration into existing development processes and environments

Excellent professional support

Have a deep understanding of their requirements and needs

Wypfler is impressed by Parasoft's commitment to providing solutions that meet the specific needs of Inomed. Because Inomed uses professional software, Parasoft makes an extra effort to fully integrate it with the solution. In addition, Inomed and Parasoft engineers worked together to solve some unique problems that must be addressed in order to establish a natural process for the Inomed development team.

"Parasoft provides absolute and strong support," he concluded. "the engineers are very qualified and every problem is solved quickly. And they are impressed by their willingness to solve the company's specific problems and requirements. Parasoft support is definitely at the top level!"

Welcome to subscribe "Shulou Technology Information " to get latest news, interesting things and hot topics in the IT industry, and controls the hottest and latest Internet news, technology news and IT industry trends.