Vantage MedTech helped redevelop remote support web application software targeted to address the underlying cause of tinnitus.
The original system was written in Flex. The system had a handheld acoustic stimuli generator, earphones, and pleasant treatment sounds. There were three sounds included, allowing the system to be customized for the patient. This flexibility enhances the effectiveness of the remote support web application software. After redevelopment, the new software allowed the doctor and patient to interact using different computers from different locations.
The software was rewritten in Java with a Moderate Level of Concern and was a Class 2 Medical device.
The new software was developed in two phases. The first phase dealt with the planning, off-the-shelf analysis, and system hardware analysis. The hazards were analyzed and mitigation plans were developed. The second phase included the design, implementation, and verification of the software. A software FMEA was used to break down the software into units and sub-units. Once requirements were clear and risks addressed, the software was implemented and tested using ad hoc and dry run testing. Any bugs found were resolved. The software was developed under the Vantage QMS and ISO 13485 and IEC 62304. After the redevelopment, the system underwent formal and ad hoc testing to reveal any bugs. The bugs were fixed to ensure the remote support web application software functioned flawlessly.
