Storke's AI agents handle the tedious tasks in medical device regulatory submissions, freeing you to focus on strategic work, take on more customers and boost your profitability.
The lengthy regulatory process often leads to rejections.
10-40 days
10-40 days
10-40 days
10-40 days
= up to 5+ months per submission
Storke revolutionizes the submission process with AI agents that automate tedious tasks, minimize errors, and significantly reduce submission time.
Reduce submission time from months to weeks, with a significant decrease in rejection rates.
Storke leverages advanced AI to automate and enhance every step of the regulatory submission process for medical devices, ensuring accuracy, efficiency, and compliance.
Automatically identifies the correct regulatory pathway for your device, saving hours of research and ensuring compliance.
Accurately classifies your device type, ensuring alignment with regulatory requirements and reducing potential delays.
Quickly find your most similar previous submissions, including success/failure rates, to leverage past experience and improve future outcomes.
Provides a dynamic, AI-generated checklist of required documents tailored to your specific submission.
Automatically generates first-draft documents, significantly reducing writing time and ensuring accuracy.
Provides AI-powered reviews of your documents, identifying potential issues and ensuring compliance before submission.
Unlock full automation by allowing Storke's AI agent to manage your entire submission process, from start to finish (optional, with human oversight).
Get instant support and answers to your questions with our built-in AI chatbot.
Clients can view project progress, make comments, and consultants can efficiently address feedback within the platform.
Maintain full control with secure team management, ensuring only authorized personnel access sensitive information.
Everything you need to know about implementing AI in your regulatory practice
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