Custom Software Development

Your team has worked hard to get your device ready for market. Don’t let faulty development keep you from securing FDA certification.

 

If the software doesn’t work,
the product doesn’t work.

Even a great device can experience delays when the software isn’t correct. With The RND Group, your software solution is specifically designed and implemented

. We translate your complex biomedical algorithms into testable cod and verify your software to ensure that your medical device software development is correct and ready for approval.

 

Compliance for Medical Device Software Development

Medical device providers appreciate our attention to detail and follow-through. We’ll help ensure your Medical Device Software Development project has all of the appropriate information in your schedule, a correct process, and the necessary architecture to meet its compliancy requirements.

 
 

Avoid unnecessary costs and delays by taking care of software risks before your submission process. Whether you’ve partnered with us from the beginning, or need an outside look at your existing medical device software development, The RND Group can help review your project against the following regulations and standards, as well as others:

  • FDA 21 CFR Part 820

  • ISO 13485

  • IEC 62304

 

Custom Development Specifics

 

Instruments/Analyzers

 

Algorithm Analysis

Intuitive User Interfaces

 

Data Reduction

 

Remote Diagnostics

Usability Engineering

 

Cloud & IoT Solutions

 

Firmware/Embedded Devices

LIS Integration

 

Mobile Devices

 

 

Experience in Agile Development

Full Project Lifecycle for Medical Device Software Development

We’re here to make sure your medical device software development is right the first time. Clients hire us to develop their medical device software from start to finish. We take a phased approach to confirm that each step honors your vision, quality standards, budget, and timeline—whether iterative or Agile.

We believe in constant communication including status reports, demonstrations, and many other forms to help us draw the essential requirements for engineering your software solution.

 

 

Intuitive UI Engineering

 

The solution must be user-friendly and aligned with CLIA regulations.

We strive to deliver both immediate and evolving value for our clients. It’s not enough to have medical device software development that technically “works”.

A careful evaluation of your goals and end-user functions help ensure we create exactly what you want in UI engineering. Our team specializes in touch-screen devices.

Tell us your Medical Device Software Development concerns, and we’ll figure out how to solve them.
Let us take your software project to the next level.