We help medical device companies develop software and AI, validate safety and security, and navigate FDA regulations—all under one roof.
You need a product-development partner for an AI-enabled imaging application.
A guaranteed regulatory plan, clinical evidence plan, and FDA Pre-Sub submitted in four weeks.
Your Breakthrough Device application drafted and filed in two weeks --- to unlock funding, faster FDA review, and market leadership.
Already have the model? We build the V&V evidence, software and cybersecurity documentation, and guarantee your AI/ML SaMD submitted to FDA in three months.
FDA flagged software, cybersecurity, or AI/ML deficiencies? We find the fastest path to clearance and write the response that lands it.
You need guidance, training, templates, and document review support for a 510(k) submission.
A lean, audit-ready ISO 13485 quality system stood up in two months --- built for SaMD teams, not paperwork.
Notion-powered FDA-submission templates and drafting tool.
You need a software-development partner for a new or existing medical-device product.
You need to determine the best path to the US market or have other custom regulatory needs.
You need help preparing cybersecurity documents for an FDA submission or to respond to a Hold Letter.
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