Funding
Funding not disclosed
Founders
Product
Problem
The medical device regulatory submission process is protracted, often requiring months of manual effort and leading to a significant rate of rejection. This inefficiency diverts regulatory professionals from strategic tasks and limits their capacity to serve clients.
Solution
Storke provides an AI-powered platform designed to automate and streamline the medical device regulatory submission workflow. The system leverages AI agents to handle time-consuming tasks, thereby reducing submission timelines from months to weeks. By minimizing errors and improving accuracy, Storke aims to decrease rejection rates and enable regulatory professionals to focus on higher-value strategic activities. The platform also facilitates enhanced client collaboration and project oversight.
Target Audience
The primary users are regulatory professionals and consultants in the medical device industry who manage submission processes and seek to improve efficiency and client throughput.
Features
- AI-driven regulatory pathway classification to ensure adherence to specific compliance frameworks (e.g., MHRA, FDA, MDR).
- Automated medical device type classification for accurate alignment with regulatory requirements.
- Predicate search functionality to identify similar past submissions, including success and failure rates, for informed decision-making.
- Dynamically generated document checklists tailored to individual submission requirements.
- AI-generated first drafts of required submission documents to accelerate content creation.
- AI-powered document review to identify potential compliance issues prior to submission.
- Optional "Full Agent Mode" for end-to-end submission process automation under human supervision.
- Integrated AI chatbot for immediate user support and query resolution.
- Client portal for progress tracking, feedback submission, and consultant response management.
- Secure team management features for controlled access to sensitive project data.