Qualmitta is a drafting and research aid. It is not legal advice, regulatory advice, or a substitute for a qualified regulatory affairs professional or an attorney.
Qualmitta itself is not a medical device. It does not diagnose, treat, cure, mitigate, or prevent any disease or condition, and is not intended to be used in clinical decision-making about individual patients.
Use of Qualmitta does not create an attorney-client, consultant-client, or fiduciary relationship between you and Qualmitta or any of its personnel. Do not rely on Qualmitta as a substitute for advice from your own qualified counsel or regulatory consultants licensed in your jurisdiction.
Content produced by Qualmitta is generated by large language models. It may be inaccurate, out-of-date, or reference regulations that have since been amended. Always verify:
Qualmitta's Patents & IP tools (patent screening, Freedom-to-Operate reports, and design-around suggestions) are preliminary AI-assisted screening only. They are not a Freedom-to-Operate legal opinion, are not exhaustive, and may miss recently issued or non-US patents. Any patent number, assignee, date, or claim summary produced by Qualmitta must be independently verified against the actual patent record on Google Patents or USPTO Patent Public Search.
Design-around suggestions are conceptual starting points for engineering exploration. They are not a determination that a modified design avoids infringement. Before making any product, engineering, marketing, or commercial decision based on Qualmitta's patent output, you must consult a registered patent attorney for a formal Freedom-to-Operate opinion.
Nothing generated by Qualmitta is a representation that a device, submission, or procedure will be cleared, approved, or accepted by the U.S. Food and Drug Administration or any other regulatory authority. Regulatory review is a rigorous human process that Qualmitta does not replace.
Data from openFDA (510(k), MAUDE) and eCFR is provided by the U.S. Government. It may be incomplete, delayed, or contain errors. Qualmitta does not warrant that any results are current, complete, or correct.
Qualmitta focuses on U.S. FDA regulations. Requirements in the European Union (MDR), United Kingdom (UKCA), Canada (Health Canada), Japan (PMDA), and other jurisdictions differ and are not comprehensively covered.
You are solely responsible for how you use Qualmitta output. You bear all risk from any decisions you make based on it, including but not limited to regulatory submissions, product design decisions, and business decisions.
Email hello@qualmitta.com if you need clarification on any of the above.