The cosmetic medical device is a modern cloud-connected device, managed by a tablet application via secure Bluetooth protocol and Raspberry Pi controlled hardware. The device not only carries out the procedure but also allows users to analyze the use of the cosmetic device in general. Comprehensive statistics gives users important data on how effective the device and methods of its use are and allows to adapt processes and methodologies to reach maximum effectiveness. Device usage statistics is saved to a web-based application that allows users to generate required report data.
Apart from management, the tablet application has comprehensive information on every applicable procedure that includes video tutorials, general description, and video lessons where applicable.
Remote cloud-based statistics management system reduces the operational load on hardware components of the device, and ensures that all medical data is kept safe.
All the components, software and hardware, are developed with compliance to the latest security and reliability standards and recommendations adopted in the EU.
HiTech Service was providing full Software as a Medical Device Development Life Cycle for this device software including analysis, software validation, software development, QA, deployment, development of process documentation using the latest technologies on the market in compliance with Medical Device Regulation, European standards and best practices.
This included software and documentation development of:
- Application for Android tablet
- Python scripts for Raspberry Pi
- Secure communication protocol over Bluetooth
- Web-based application for reporting
- API to communicate between Android tablet and web application
Software development and certification preparation process were done according to:
- ISO 13485:2016 “Medical devices — Quality management systems — Requirements for regulatory purposes”
- EN/IEC 60601-1 “Medical Electrical Equipment and Systems”
- ISO 14971 “Medical devices — Application of risk management to medical devices”
- IEC 62304 “Medical device software — Software life cycle processes”
- IEC 62366 “Medical devices – Application of usability engineering to medical devices”
The cosmetic medical device has successfully passed the certification process and is going to the market.
Our team has good experience in developing software as a medical device, backed up by knowledge in European Union Regulation of Medical Devices, Regulatory Requirements in Healthcare, Safety Risk Management.