We help medical device companies develop software and AI, validate safety and security, and navigate FDA regulations—all under one roof.
You need a strategy for bringing AI/ML-enabled software onto the US market.
You have a nearly finished product but no documentation, and need to submit a 510(k) ASAP.
We guarantee AI/ML SaMD FDA submission and clearance in 9 months.
FDA identified major cybersecurity, software, or AI/ML deficiencies that you need help resolving.
We guarantee submitting your presub and BDD in 4 weeks. Need it faster? We can do it in as little as 2 weeks with daily meetings and a rush fee.
We guarantee your BDD application in 2 weeks. Unlock funding, accelerate FDA review, and signal market leadership.
Notion-powered FDA-submission templates and drafting tool.
You need a product-development partner for an AI-enabled imaging application.
You need Quality Management System implementation and/or support.
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 guidance, training, templates, and document review support for a 510(k) submission.
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