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FDA Compliant Software Solution for a Global Medical Device Manufacturer

 

About the Customer:

Our Customer is a leading manufacturer of Medical Weighing Scales and Measuring instruments. They are a world leader with business footprint spread across more than 100 countries.

Business Challenge:

The customer was looking for a robust software solution, that could inherently address existing limitations and enhance the functionality of one of their medical device product lines.

They were confronted with the following challenges:

  1. Support for rollback of a remote firmware (OTA) upgrade was missing.
  2. Though the medical devices were developed for global audience, there was support for only a limited number of global languagesThe customer wanted a cost-effective solution to extend the number of languages in which the system content is displayed. This was necessary to enhance the global level usability of their medical devices.
  3. Stringent FDA regulatory requirements: Customer felt the need for expert guidance in embedded software development, as per the FDA standards

FDA

Embitel Solution:

After initial brainstorming sessions and technical workshops, the customer found a reliable technology solution partner in Embitel.

Embitel’s embedded software development team, consisting of Firmware developers and test engineers, got on-board. They performed an in-depth analysis of the software architecture of the medical device.

Let us have a quick look at the solution roadmap, which was followed by this team:

  1. Enabling Multi-Language Support: We customised and re-configured the software of the devices, to extend support for multiple languages. We also enabled the end-users, with the feature , to set and see the content, notifications alerts & more, in their preferred language.
  2. Enabling Rollback of Firmware versions: Embitel implemented a solution to enable rollback of any upgradation of firmware image on the field devices through firmware-over-the-air(FOTA).
  3. Configuration & Customization of Admin & Security Settings: We enabled the end-user (with valid credentials), to configure the medical device as per his/her requirements. Earlier, only an admin user could configure the system with a pre-defined universal admin credential.We also developed a custom login solution, whereby an end-user can create a custom password on switching on the system for the first time.  This also facilitated an enhanced security against any unauthorized system access.
  4. Enabling Custom maintenance Schedule for the devices: The devices were programmed for customized maintenance and service schedule. This has enabled the user to set custom service reminders, as per their convenience
  5. New UI (User Interface) for Better CX (Customer Experience): The device UI was given a make-over by designing a new interface for admin support, multi-language support – as per the wireframe shared by the customer.
  6. Quality Check at every stage of the development process: Rigorous Code quality checks were carried out for bug detection. This also helped to check the software against any vulnerability that may have got introduced during the development stage.
  7. Testing : We performed manual and automated testing of the software solution.
  8. Customized development process as per the FDA guidelines: We followed a custom software ( design, development, update) processes, which were strictly verified for FDA compliance. And in order to ensure FDA-compliance, we performed a project impact analysis to evaluate the impact of the proposed changes on the end device.

 

Embitel Impact:

  1. Our domain knowledge and on-field experience proved to be a value-add.
  2. Our team was able to, identify & implement innovative business logic, for the challenges and requirements specified by the customer.

Tools and Technologies:

  • Qt software toolkit
  • Linux OS
  • SQL database query language

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