Get to market faster with our expert services.
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.
Empower medical device innovation with our solutions for particular business situations.
You need guidance, training, templates, and document review support for a 510(k) submission.
We guarantee submitting your AI/ML SaMD FDA application in 3 months and guarantee FDA clearance.
FDA identified major cybersecurity, software, or AI/ML deficiencies that you need help resolving.
We guarantee submitting your presub and BDD in 2 weeks.
We guarantee your BDD application in 2 weeks. Unlock funding, accelerate FDA review, and signal market leadership.
You need Quality Management System implementation and/or support.
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
Email (general)
info@innolitics.com
Email (sales)
sales@innolitics.com
Phone
+1 (512) 967-6088
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