Radiology Software Fast 510(k)

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, 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.