Custom Medical Device Software Development

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

Even a great device can experience delays when the software isn’t correct. But with The RND Group, your software solution is specifically designed and implemented. We translate your complex biomedical algorithms into testable code. Then we can verify your software to ensure that your Medical Device Software Development is correct and ready for approval.

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 routinely 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.

The RND Group is experienced in Agile development and has successfully applied our internal Agile process for Medical Device Software Development. Asking thoughtful questions along the way and staying in constant communication (status reports, demos, etc.) helps us draw out the essential requirements for engineering your software solution. We view ourselves as servants both to our clients, and to those who will be benefit from the solutions we create together.

Compliance for Medical Device Software Development

You avoid unnecessary costs and delays by taking care of software risks long 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

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.

Intuitive UI Engineering

We always strive to deliver both immediate and evolving value for our clients. It’s not enough to have Medical Device Software Development that technically “works” for your device. The solution also needs to be user-friendly and aligned with the CLIA regulations.

A careful evaluation of your goals and end-user functions help ensure we create exactly what you want in UI engineering. Our team also has a specialization 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.

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



Usability Engineering

Algorithm Analysis

Cloud & IoT Solutions

Remote Diagnostics

Intuitive User Interfaces

LIS Integration

Data Reduction

Mobile Devices

Firmware/Embedded Devices

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