Cartridge Based Detection System

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

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