What is this tool?
This is an AI agent assistant that gathers information about your new medical device through a series of questions and seamlessly generates the critical documents required for filing with various medical device regulatory agencies, such as marketing and product requirements, risk assessments, and verification and validation plans. Additional features make editing and iterating on the documents with the AI assistant easy and efficient, allowing you to focus on the device design without worrying about cumbersome documentation requirements.
Functionalities:
Feasibility Analysis
Learn the likelihood of your device's success based on its features and design.
- Get guidance for:
- What areas need improvement.
- What adaptations to make.
- Solutions to commercial issues that may arise.
Marketing Requirements
Learn how your device compares to already-existing devices currently on the market.
- Get guidance for:
- Setting your device apart.
- How to price your device.
- How to address barriers when getting your project on the market.
Product Requirements
Learn how your medical device measures up to national and international standards and regulations.
- Get guidance for:
- Addressing usability and patient needs.
- Perfecting your design.
- Mitigating hazards.
Risk Assessment
Identify the kinds of hazards your device poses to the user, as well as their severity and likelihood.
- Get guidance for:
- What risks to focus on.
- How to control those risks.
- Evaluating persisting hazards after controls have been implemented.
Verification Plan
Ensure that your project's design meets all ISO safety and performance requirements.
- Get guidance for:
- Statistical approaches.
- Required resources to support your device.
- Documentation templates.
Validation Plan
Ensure that your project complies with ISO 13485 for the usability and intended use of your medical device.
- Get guidance for:
- Required resources to support your device.
- Documentation templates.
- High-risk use scenarios.
FAQs
Please reach out to the person who helped you set up your account. We are happy to answer questions and learn about any issues you run into.
More information coming soon!
At the current time, it is recommended that you do not submit any confidential or intellectual property to this system. Any and all submissions should be made merely for testing purposes.
View our full privacy policy and security details here.