Companion Diagnostic Device using NGS
Leveraging IoT for Medical Device Software
RND Group Assists in Acquisition Assessment and Remediation
Partnership to Build Pharmaceutical Compounding Device
The RND Group Builds Cloud Solution for Infectious Disease Surveillance and Reporting
Rheonix Partners with The RND Group to Assist with Encompass
Convergent Dental Partners with RND Group to assist with Solea System
InstantLabs Partners with RND Group for Enhancements to the Hunter System Software
Cartridge Based Detection System
Software Engineering for DNA Detection Platform
User Workflow and Interface Design
Opportunity:
Our client had “Proof of Concept” level software with no established design controls. The software was needed for critical beta/clinical trial timeline. Our client’s success was dependent on meeting milestones with quality software.
Results:
RND took over all aspects of the software including communications and firmware. RND established a design history file, configuration control, and a plan to meet the customer’s milestones. RND is currently meeting those milestones.
Capabilities Applied
FDA Part 820, Part 11
Windows Development
Software Verification
ISO 13485 Quality System
Requirements Management
Firmware/Embedded Programming
Software Lifecycle
Project Management
Software
Instrument/Analyzer
Algorithm Analysis
Firmware/Embedded Devices
WPF UI Design/Development
Data Reduction
LIS Integration
Database Development
Technologies Used
Python
C#, WPF Development
