---
AI Summary: "\\- Completed software documentation for FDA 510(k) submission in 4 months.\
  \  \n- Technologies used: MedTech OS, source code analysis.  \n- Onsite collaboration\
  \ with client\\'s engineering team to produce required documents, including Software\
  \ Requirements Specification and Cybersecurity Management Plan."
Anonymous: false
Assignee:
- J. David Giese
Last Edited Time: '2026-01-26T00:03:00+00:00'
case_study_510ks: []
client_logo: []
client_name: International IVD Manufacturer
date: '2024-01-24'
featured: true
medical_panel: Microbiology
name: We Flew Onsite, Read the Code, and Finished the 510(k) Docs in 4 Months
services:
- 6d5e46e7-72da-4217-bdd9-c1c771f2f696
- 299bd5b7-a754-8036-8380-d6165b0c1670
summary: Other consultants couldn\'t make progress. We finished their software docs
  in 4 months --- 3x faster than expected.
tags:
- 510k
- IVD
testimonials:
- e1875ccf-db1e-4558-a39b-afb07cb5fd81
---

## The Problem

The client, an international IVD manufacturer, was working towards FDA clearance for their breakthrough IVD device. The software and firmware was nearly complete, but they didn't have software or cybersecurity documentation. It was starting to look like it would become the bottleneck for the project.

They'd worked with a few regulatory consultants and regulatory writers working on an hourly basis, but they weren't making progress. The VP of Software Engineering was looking for a group that could

1.  Make rapid progress on the software documentation, making way for their 510(k) submission
2.  Keep his engineers (mostly) focused on software development.

## The Outcome

We completed the software documentation for the submission in 4 months, while allowing their engineers to stay (mostly) focused on software development.

<div class="pl-3 border-solid border-0 border-l-4 border-gray" custom-style="Block Quote" markdown="1" role="blockquote">

Thanks to Innolitics, we were able to complete the software documentation for our 510(k) in just 4 months. Their engineers flew onsite to absorb how our software worked and provided detailed guidance every step of the way. Without their MedTech OS, training, and support, I can easily imagine the process taking 12 months. Our engineering team was able to focus on feature development instead of being bogged down with documentation. Innolitics truly made a difference in our success!

--- VP Software Engineering

</div>

## The Solution

We followed our [Fast 510(k) process](https://innolitics.com/services/510ks/).

The project team flew on site, learned about the software and the device, read through the source code, and worked with their team to complete the following documents:

- Level of Concern
- Software Description
- Device Hazard Analysis
- Software Requirements Specification
- Architecture Design Chart
- Software Design Specification
- Four Detailed Software Design Specifications
- Traceability Tables
- System Test Protocols
- Revision Level History
- Unresolved Anomalies
- OTS Software Report
- Security Risk Assessment
- Software Bill of Materials (SBOM)
- Cybersecurity Management Plan
- Human Factors Engineering Report