The Client

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.

Why they chose RND

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.

Full life cycle services

The RND Group provided full life cycle software services in the development of the system controller and user interface.
This includes:

• Analysis

• Requirements definition

• Software design

• Software implementation

• Software unit and integration testing

• Software verification.

Accelerating the timeline

This solution utilized The RND Accelerator, our proven framework rich with features common to every project that has been tested and integrated into many of our projects. This caused a rapid increase in progress for the initial software, which was then customized to this project.

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.

Results

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

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

Your project deserves a specialist.
Contact us to see how we can assist with your project here.

Capabilities Applied

FDA Part 820, Part 11

API definition and development

Project management

ISO 13485, HIPAA, IEC 62304

Requirements development and management

Software verification

Software life cycle processes

Software risk analysis and management

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

Microsoft SQL Database

Model-View-ViewModel (MVVM)

Microsoft C#