Storke is a regulatory provider specialising in Class I-IIb medical device submissions. We get devices to market faster, without compromising defensibility.

We build AI agents that generate regulatory documentation at machine speed. Every output is then reviewed by our expert consultants, who check for completeness and primary-source traceability. 

Speed and quality, in the same engagement. Our scope covers the submission lifecycle end-to-end: classification rationales, literature reviews, clinical evaluations, risk files and technical files.