The Need
Our Client was in the process of getting FDA approval for their Electroporation device and received several concerns and was looking for a partner who could help them in the analysis, identification, and resolution of the gaps so that the device become FDA-certified.
Impacts Delivered
- Gadgeon collaborated with the customer in reviewing the firmware code and identified the gaps followed by the implementation of fixes.
- The device has cleared the FDA approval in the first resubmission itself.
- Created a tool to generate unit test cases from the source code. This reduced ~30-40 % overall effort and schedule.
- Design and execution of V&V activities as per FDA guidelines:
- Executed unit tests, integration tests, and COTS tests for the device firmware.
- Performed static analysis and code review of code and produced the reports.
Our Solution
- We performed the detailed Validation and Verification activities as per the plan created:
- Third-party RTOS and library upgradation
- Static analysis and bug fixes
- Unit test updates for new library changes
- Integration test and validation
- COTS test and validation
- Protocol updates
- Tools validation
- GIT validation protocol
- Bug fixes
- Updated device code with the bug or gap fixes.
- GIT validation protocol and report
- Executed the updated Unit test cases and report generated
- Updated Integration test code and report
- Updated COTS test code, protocol, and report
- System Test protocols and reports for treatment, UI, Timer, and Error protocols.
- Updated PC Tool Report
Final Tester – A Web Application for Test Case generation.
- A Web application was developed for test case creation
- The application created test scripts with various parameters.
- The application was implemented with features such as support for multiple user roles with different levels of approval authority and access to the application and options to download/upload the scripts and
- The final tester provides API based interface
Device Data Management tool
- A web application was developed that allowed the users to upload device specific binary log files
- The application implemented multiple features such as:
- Parsing and filtering of data,
- Export the data to Excel or pdf formats,
- review of treatment details, add review notes, and manage treatment review.
Tools & Technologies
- .Net 5, Asp.Net Core
- Data Serialisation using Google protobuf format and protobuf message parsers
- .Net Web API with JWT Authentication and Swagger UI
- Azure CDN for the report and other artifact storage
- dotnetZip
- PDF generation using iTextSharp library
- Logging and error handling with Nlog
- Unit Testing using XUnit
- Entity Framework ORM on top of SQL Db
- Life cycle followed - Agile and was fully CAPA compliant
