Leading Medical Device Manufacturer Partners with The RND Group to Build Pharmaceutical Compounding Device

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The RND Group  recently completed a project with an industry-leading medical device company to develop a state of the art pharmaceutical compounding system.  The system allows for individualized patient nutritional mixtures to be compounded in a safe, accurate and efficient manner.   The system will be marketed to hospital and outsourcing pharmacies.

The RND Group was recommended to this established medical device company by the hardware vendor as a continued line of successful projects between The RND Group and the vendor.

The RND Group provided full life cycle software services in the development of the system controller and user interface; including analysis, requirements definition, software design, software implementation, software unit and integration testing and software verification. The result of this joint effort is a robust pharmaceutical compounding device that is state of the art in terms of safety, accuracy and throughput.  The software project was completed using The RND Group’s design control procedures which meet applicable FDA requirements.

The complete software deliverable from The RND Group provided management of the compounding control panel including the user interface, workflow, data management, reporting, device communications and device management.

The solution developed by The RND Group was architected to leveraged The RND Group’s Application Accelerator rapidly getting the initial software frameworks in place with a high level of confidence and rich with features.  Custom development added integration with a proprietary data library allowing the system to be data driven in many aspects.   The development was done in parallel with the compounding hardware design.   Streamlined communications and continuous integration allowed for steady progress despite being a multi-company project team dispersed across 4 locations with over 120 team members.

The system was released to consumers in early 2017.  The RND Group continues to provide software support implementing new and enhanced features.

 The RND Group specializes in the definition and delivery of FDA-regulated software for medical devices. We are a team of people who excel in our craft, blending skill with passion to build software to meet exacting standards. Each project is developed with an unmatched attention to detail, a tireless passion for perfection and a drive to architect a solid foundation for the future.

With over 20 years of experience in regulated software engineering, we’ve built a heritage and reputation for building specialized software with precision and care. The RND Group can point with pride to products that have been successfully introduced into the medical device marketplace

 

Capabilities Applied

  • FDA Part 820, Part 11
  • ISO 13485, HIPAA, IEC 62304
  • Software life cycle processes
  • API definition and development
  • Requirements development and management
  • Software risk analysis and management
  • Project management
  • Software verification

Software

  • Microsoft Windows Presentation Foundation WPF user interfaces
  • Asynchronous Serial Command and Control of hardware device
  • HID Barcode Reader Integration

Technologies Used

  • Microsoft WPF + Prism
  • Model-View-ViewModel (MVVM)
  • Microsoft C#
  • Microsoft SQL Database