Simplify your regulatory journey
You are at the right place to understand what is required to put your medical device or digital health service on the market and to keep pace with the continuous flow of new FDA guidance.
What are we offering?
Summary of FDA guidances
All new guidances are automatically processed by our AI-agent to summarize the scope of the new issued guidances by the FDA.
Save time when there is a new guidance by checking in less than 3 minutes if you are concerned by the guidance and what are the recommanded actions.
All guidances are accessible by the top search bar or in our knowledge base.
Virtual QA/RA (coming soon)
You can have a chat directly with our virtual QA/RA manager to understand better a guidance or a specific topic.
Any questions or inquiries?
Feel free to contact our support team by email.