By accessing or using Qualmitta (the "Service"), operated by Qualmitta, you agree to be bound by these Terms of Use. If you do not agree, do not use the Service.
Qualmitta is an AI-assisted drafting and research tool for medical device regulatory workflows. The Service helps you draft templates (510(k), PMA, De Novo, IFU, DHF, Risk Management, and similar), research FDA regulations, and analyze public FDA data (openFDA, MAUDE, eCFR).
Qualmitta is not a law firm. Nothing produced by the Service is legal advice, regulatory advice, or a guarantee of clearance or approval by the U.S. Food and Drug Administration or any other regulatory authority. All output must be reviewed by qualified regulatory affairs professionals before use in a real submission.
You must be at least 18 years old and legally able to enter into this agreement. You agree to provide accurate information (including a working email address) and are responsible for activity on your account.
You retain ownership of the inputs you provide and the outputs you generate. You grant Qualmitta a limited license to store and process those inputs and outputs solely to provide the Service to you.
The Service uses large language models that can produce inaccurate, incomplete, or outdated information. Regulations change. Always verify citations, dates, and requirements against the current text on eCFR, FDA.gov, and other authoritative sources.
Qualmitta surfaces data from public sources including openFDA and eCFR. Those services are provided by the U.S. Government and are subject to their own terms of use and availability. Qualmitta does not warrant the completeness or timeliness of that data.
Qualmitta's patent screening, Freedom-to-Operate (FTO) reports, and design-around suggestions are AI-assisted screening only. They are nota legal opinion, are not exhaustive, and cannot be relied on as a determination that a product does or does not infringe any patent. You must independently verify every patent citation on Google Patents or USPTO Patent Public Search and consult a registered patent attorney before any product, engineering, marketing, or commercial decision. Qualmitta accepts no liability for decisions made in reliance on its patent-related output.
THE SERVICE IS PROVIDED "AS IS" WITHOUT WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, AND NON-INFRINGEMENT.
TO THE MAXIMUM EXTENT PERMITTED BY LAW, QUALMITTA WILL NOT BE LIABLE FOR ANY INDIRECT, INCIDENTAL, SPECIAL, CONSEQUENTIAL, OR PUNITIVE DAMAGES, OR ANY LOSS OF PROFITS OR REVENUES, ARISING OUT OF YOUR USE OF THE SERVICE.
You may stop using the Service at any time. We may suspend or terminate access if you violate these Terms or if we discontinue the Service.
We may update these Terms from time to time. Continued use of the Service after changes constitutes acceptance of the updated Terms.
Questions about these Terms? Email hello@qualmitta.com.