You may also be interested in the companion article, “How to Grow a 10x Team with Code Review.”
Medical Device Software Development
We design, build, and document regulated software alongside your team, ready for FDA submission.
ArticleAI/ML
FDA's warning letter to O.N. Diagnostics says three changes in VirtuOst VFA 3.0.0 (a new machine learning algorithm, a desktop-to-web move and a platform migration) each require...
Yujan Shrestha
ArticleAI/ML
Before asking how to document the cloud, ask why you are submitting it. A review of FDA-cleared binaries and libraries shows how sponsors separate their medical software from th...
Yujan Shrestha
ArticleAI/ML
The myth: a real-time or in-procedure indication needs a hardware device. We screened all 1,483 AI/ML-flagged FDA records and found 50 verified clearances where software-only de...
Yujan Shrestha
Every great partnership starts with a conversation. Fill out the form below for a discovery call, and an Innolitics team member will contact you soon.
I learned more from an hour-long Innolitics sales call than an entire paid engagement from other consultants.
Richard Clark
Executive in Residence at Washington University
