Qualitest Provides Improved and Efficient Embedded Software Testing Services to Global Healthcare Corporation
When you’re tight on time and need to ensure you comply with FDA guidelines, choosing the right testing expert determines your product’s success.
The client is a leading diversified technology corporation with 3 main divisions. Their healthcare division is one of the largest international healthcare corporations, with more than 120,000 employees worldwide.
Business Needs and Objectives
Our client was developing a technology that combined robotics, sensors, power systems, actuation, and complex embedded software to deliver a product that is far more advanced than any device currently available. The software was designed with a distributed microprocessor and micro-controller architecture. Concerns had been raised by the business about this new technology due to:
- Tight project timeline and the need to maximize productivity
- Need for increased software quality given the safety-critical and real-time requirements
- U.S. Food and Drug Administration (FDA) guidance for medical devices strongly recommends the use of static analysis.
QualiTest was asked to review the system and provide confidence that there would be no critical issues and reduce the risk of software failure in the field.
The Qualitest Solution
Qualitest Group provided the customer with managed testing services (MTS). Qualitest’s MTS are provided and managed by QA and testing professionals, assuming full responsibility for the project, delivering results based on a pre-defined service-level-agreement (SLA) and measured on agreed key performance indicators (KPIs).
Qualitest Group assembled a number of dedicated teams in multiple locations, including Ohio, USA, Haifa, Israel and Bangalore, India. The team included a total of about 30 system engineers, testing and quality assurance experts. The group was able to start working quickly, operating through a Qualitest Test Center of Excellence that was located in close vicinity to the customer’s premises, as well as on the customer premises per customer need.
The software team was impressed by Qualitest Insight’s defect detection capabilities. Since the software is an embedded real-time system, defects such as array bounds violations, use of uninitialized data and thread synchronization errors were potentially critical issues that were found by the Qualitest team. Many of these issues are very difficult and challenging to manifest and isolate during testing, and could potentially lead to unexpected behavior and software failure in the field. Qualitest engineers also found potential security vulnerabilities where the software wasn’t validating integer use, a vulnerability type that could allow malicious users to access the system’s communication protocol and cause system failure or inject malicious code. While medical devices aren’t high targets for hackers, the Qualitest team takes the security and robustness of its customer’s software seriously and reported all potential situations similar to these.
The major achievements during the review included:
- Quality: Tuning recommendations were provided to the client so that the application met requirements.
- Cost: By using Qualitest MTS partnership, the customer was able to save on overhead management cost.
- Time: Although it was a tight timeline, the project was completed as planned.
- Project summary and dashboard that showed key metrics and fix activity
- List of top defects and their severity to prioritize investigation based on criticality
- Source code size and complexity to monitor key components whose complexity can impact run-time performance