Fast 510(k) for Breakthrough IVD

International IVD Manufacturer

FeaturedFast 510(k)510kIVD

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.

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

The Solution

We followed our Fast 510(k) process.

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