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SAMD App Development

Reliable and Accelerated 
Software as a Medical Device App

You know how Mobile Apps are notorious for their bugginess and unreliable operation? Well, we have developed a fully software-engineered Template Mobile App (TMA) that delivers all the reliability you need for a medical App.

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  1. What we do: We develop medical Apps including the user interface, application logic and all the support facilities.
     

  2. We accelerate it: By building your App on top of our template, all of the under-the-hood facilities around navigation, user management, graphical data display, cybersecurity and data integrity come out-of-the box.
     

  3. We smooth the regulatory compliance pathway: By using our modularised software and templates developed under medical device design controls and addressing issues of using an uncontrolled mobile device platform, we make your regulatory compliance tasks much easier. 

Want to accelerate the path to compliance for your medical mobile app? 

App - core facilties

Core facilities

The TMA comes with all the facilities you need, saving time and money developing these from scratch.
 

Core facilities include:

  • Navigation Menu: The template comes with standard navigation features, including drop down menu and universal navigation links on every page.
     

  • Help Menu: Developers can customise a help menu to provide users instructions.

  • User profiles: Define different classes of users and show them different menu options. 
     

  • Account management and user authentication: Set logon passwords for each user and assign rights and privileges.
     

  • Settings: Configure the App itself to determine what pages users see, adjust the formatting and layout, adjust notifications, configuring backups etc.
     

  • Branding: Easily change the colour scheme and add your logo.

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App - data visualisation
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Data visualisation

We understand that mobile Apps need to look slick but it shouldn't be hard to convert data into great visualisations. We've worked hard to make this job easy including:

  • Self-describing data models: We manage data in a format that allows whatever platform is displaying it to instantly understand what the content is. This means your data can be easily displayed on an embedded display, your mobile App or cloud website. 
     

  • Graphical display widgets: The TMA comes with widgets for displaying data in a line chart, bar chart or tabular format. Other formats can be easily developed on request. 
     

  • Dashboards: Dashboards integrating data from multiple sources are easily constructed in your App. 
     

  • Display configuration: Easily adjust the data displays by adjusting settings on the display user interface.

Our value add services

Seamless App / Cloud Integration

High reliability is about delivering the data accurately. Key features supporting data integrity in the TMA are: 

  • File management: The App includes file transfer facilities and provides direct access to, and integration with, the mobile's OS file system. 
     

  • Cross Platform: No matter what medical environment your device is deployed in, the Template App will work. It was developed in React Native, which allows one App to be deployed across multiple platforms including iOS and Android. It can also be adapted to work in a PC environment.
     

  • Cloud Connectivity: Seamlessly connect the App to AWS, Azure, Google Cloud or other cloud servers for data uploads, enterprise connection, backups, pushing of device updates and more.

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Reliability and debugging

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High reliability is about delivering the data accurately and progressively eliminating any bugs in the programming. Key features supporting high reliability in the TMA are: 

  • Debugs: The App facilitates command line inputs to the device and streaming device debugs.

  • Event logging: Software events are logged and saved in the App file system and a crash reporting system ensures alerts are issued.
     

  • Cyclic Redundancy Checking (CRC): This error detection technique underpins our data integrity approach, ensuring that data has been received without any errors.
     

  • Packet tracking: This technique tracks individual data packets during transmission, ensuring that packets are in the correct sequence when used at the destination.
     

  • Time synchronisation: We ensure that the clocks of all elements in the system are synchronised to a common time standard, supporting coordination, correct order of data processing, accurate event logging, time stamping of data, time-based security features, de-bugging and much more.
     

  • OTA updates: The App can be updated via Over-The-Air updates from the cloud. 
     

  • Application monitoring: We employ the Sentry platform for gathering errors to monitor and ensure stability and performance in the deployed App.

Medical Compliance

Mobile Apps for medical devices are fraught with regulatory compliance risk because of the uncontrolled nature of the mobile device platforms that the App runs on. In addition to recommending the device be run in Kiosk mode and controlling the operating system version, Genesys has addressed this in a number of ways: 
 

  • SOUP Wrapper: We place a wrapper layer around all operating system calls which facilitates proper sanity checking and error handling. It also provides a structured method for software unit testing and arguments boundary tests which is required for medical software.
     

  • Medical record generation: We have built the App from the ground up to generate the kind of records required of medical applications, including data integrity, security, data logging / timestamping and other features.
     

  • Pre-compliant software modules: The core software modules that underpin the Template App have been developed under design controls with all the documentation in compliance with the medical software lifecycle standard IEC 62304.
     

  • Documentation templates: If you know about medical device projects, you will know about the huge amount of mandatory documentation required. Genesys has a template of every document you will need for your design and development file, that will comply with the requirements of the various standards.
     

  • Usability Engineering: The user interface elements of the Template App are currently being tested under the IEC 62366 usability engineering standard.
     

  • Privacy and Cybersecurity: We include all the security features you and regulators would expect including user authentication with safe password storage, two factor authentication, use of secure communication transport protocols, data encryption of data transfer, and we cover all vulnerabilities including password protection on streaming debugs between mobile phone and the cloud.

 

Learn more about the full scope of Genesys' medical device development services.

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For a page-by-page walk through of the Template Mobile App, showing all the details, contact us for a free demonstration
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