Healthcare - TestOps

Medical devices, due to their criticality coupled with intricate hardware and software, makes them one of the more complex systems to engineer in the field of Healthcare.

Engineering for safety and reliability of medical devices is of utmost importance and manufacturers spend a large share of efforts in achieving this over adding newer capabilities.

It is fair to assume that the first customer of the medical device manufacturer is a regulatory body. Their acceptance and approval are mandatory for the manufacturer to further offer to a wider range of customers in the market. ISO 13485 coupled with IEC 62304 are among the key standards that clearly define the requirements for a comprehensive quality management system and software life cycle processes. Manufacturers must strictly adhere to these standards and achieve the required criteria for acceptance and approval by several regulatory bodies across the world, the key ones being the US FDA, EU’s CE, China’s CFDA etc…

Design, development, and testing are the core functions in the field of engineering. Especially for product engineering in the healthcare domain, testing takes a significant portion of the effort to achieve the required quality. Testing not only ensures the products’ software and devices are fully compatible and compliant with various regulations but also deliver highest quality functionality. End users also expect exceptional performance, effectiveness and safety from the devices that they use. This compels medical device manufacturers to create and deploy testing strategies at their optimal best, usually translating to longer release cycles and higher costs.

The greatest challenge for a medical device manufacturer is a quick product release that meets stringent quality and regulatory criteria. Regulatory approvals often delay product release leading to a high business impact.

GAC’s Robotic Test Automation TestOps Toolkit (an IP/Product based offering) provides a powerful and cost-effective solution for your testing portfolio. A specialized, professional services with expertise in the medical devices industry, leveraging Robotic Test Automation (RTA) as a service.

GAC’s RTA Toolkit:

  • enables our clients to minimize the involvement of automation testers while allowing manual testers more time for exploratory testing.
  • is preconfigured to drive increased quality and learn and work more efficiently and effectively over time.
  • works with your existing test automation and any other tools that are already in place.

Goal: Transformational increase in delivering quality to your customers and further speeding up your market release.

GAC’s RTA Toolkit also addresses the testing of:

  • Repetitive tasks.
  • Tasks which are humanly not possible

This leaves manual testers to focus on high cognitive human tasks.

GAC guarantees the following benefits with the RTA toolkit:

  • Quality improvement — automation coverage increased to 70-80% (normally 20-40%).
  • Speed up test execution cycles enabling faster market release.
  • Provide the know-how to handle FDA regulatory authorities, specifically quality standards.
  • Save cost by eliminating the need for automation engineers.

Our RTA tool runs on premises: workstation/desktop, client server, web, and cloud-based systems.