Go Regulatory Ltd ("we", "us", "our") provides the GORA AI platform to help regulatory affairs professionals organise pathway research, checklists, templates, and market intelligence for cardiovascular medical devices. Everything the platform produces — guidance text, checklists, pathway summaries, cost estimates, or document drafts — is informational only. It does not constitute legal advice, regulatory advice, a formal regulatory opinion, or professional certification of any kind, and it is not a substitute for review by a qualified regulatory affairs professional or legal counsel.
Using GORA AI does not create a client relationship, advisory relationship, or fiduciary duty between you and Go Regulatory Ltd. We are a software provider, not your regulatory consultant, legal representative, or agent before any regulatory authority.
Regulatory frameworks — including EU MDR, UK MHRA, FDA/CDRH, and other national requirements — change frequently and are interpreted differently across jurisdictions and product classifications. While we work to keep the platform's rule logic and reference data current, we do not warrant that any output is complete, accurate, or up to date, or that it applies correctly to your specific product, technical file, or circumstances. You are responsible for verifying all guidance against the current primary source published by the relevant regulatory authority before acting on it.
Nothing on the platform guarantees or predicts that any device will achieve regulatory approval, clearance, or certification, or that any timeline or cost estimate will be met. Regulatory outcomes depend on factors outside our control, including the completeness of your own technical documentation and the judgement of the reviewing authority or notified body.
The platform may reference or link to external regulatory authority websites, published fee schedules, or other third-party resources for your convenience. We don't control these sources and aren't responsible for their accuracy, availability, or content. Always check the authority's own published guidance as the definitive source.
This disclaimer should be read together with the limitation of liability and disclaimer of warranties set out in our Terms of Service, which govern the extent of our liability in full.
Questions about this Disclaimer can be sent to support@goregulatory.com or Go Regulatory Ltd, Homelands, Rock Hill, Orpington, United Kingdom, BR6 7PP.