---
AI Summary: "\\- Assisted a software services firm with their first medical device\\\
  's 510(k) clearance in 12 months.  \n- Utilized Medtech OS and the Fast 510(k) process\
  \ for documentation.  \n- Enabled engineers to focus on software development while\
  \ navigating regulatory requirements."
Anonymous: false
Assignee:
- J. David Giese
Last Edited Time: '2026-01-25T23:11:00+00:00'
case_study_510ks: []
client_logo:
- 18dbd5b7-a754-8090-b4b0-ebf11760acae
client_name: Software Services Firm with First Product
date: '2024-01-18'
featured: true
medical_panel: Radiology
name: We went from Zero Documentation to 510(k) Cleared in 12 Months
services:
- 6d5e46e7-72da-4217-bdd9-c1c771f2f696
summary: Client\'s first medical device. No documentation. 510(k) cleared in 12 months
  while engineers stayed focused on dev.
tags:
- 510k
testimonials:
- d8474389-dec7-41c3-a603-0786bc9a2440
---

## The Problem

Client was an established services firm. They were looking for help with regulatory clearance for their first medical device product. A significant portion of the software work was already complete.

They were looking for help:

- Identifying which software features to include in the their initial release
- Writing the software and cybersecurity documentation
- Navigating the FDA submission process.

The client was looking to complete the project in time for an annual trade conference, and needed a partner who could pull as much of the burden of their team, and especially their engineers, as possible.

The client's CEO, had worked with several regulatory consultants in the past. In his experience, most of them could provide templates and high-level guidance, but most of the software and cybersecurity work still fell on the engineers. Furthermore, this was work the engineers didn't enjoy.

## The Outcome

The client submitted their 510(k) 9 months after starting the engagement. The delays were primarily related to unforeseen software development and issues found during design validation. They received 510(k) clearance 12 months after starting the project.

Throughout the process, their software engineers were able to stay focused on development.

## The Solution

We then used Medtech OS and our established [Fast 510(k) process](https://innolitics.com/services/510ks/), to guide the team through writing the documentation needed for their submission.

We began by developing a clear regulatory strategy which included an understanding the impact on the regulatory pathway, costs, and timelines of including various software features in the first release.