1. Who these terms are between

These terms of use govern access to the Qevatrix website at qevatrix.com and to every Qevatrix application, including DeviceOS, QualityOS, RegulatoryOS, ClinicalOS, EvidenceOS, StudyOS and TrademarkOS (each an "Application").

By creating an account, signing in, starting a trial or purchasing a subscription, you agree to these terms on behalf of yourself and the organisation you represent. If you do not agree, do not use the Applications.

2. Accounts and access

Accounts are issued to named individuals. Credentials must not be shared, and each user of a regulated Application must have their own account so that electronic records and signatures are attributable to a single person.

Your organisation's administrators control who is invited, what role each member holds and when access is removed. You are responsible for keeping that member list accurate and for all activity carried out under your accounts.

We may suspend an account immediately where we reasonably believe it has been compromised or is being used in breach of these terms.

3. Subscriptions, trials and payment

Subscriptions are sold per Application and per plan tier as published on the pricing pages, or under a written enterprise agreement. Prices shown exclude taxes unless stated otherwise.

Free trials run for the stated period and convert to a paid subscription only if you choose to continue. Trials may be cancelled at any time before the trial ends without charge.

Paid subscriptions renew automatically for successive terms until cancelled. Cancellation takes effect at the end of the current billing term; fees already paid are not refundable except where required by law.

4. Acceptable use

You must not attempt to breach or probe the security of the Applications, reverse engineer them, resell access, upload malicious code, or use the Applications to store content you have no right to hold.

You must not use the Applications to falsify records, backdate entries or otherwise defeat the audit trail, electronic signature or record-integrity controls they provide.

5. Regulated use and your responsibilities

Qevatrix Applications support quality, regulatory and clinical processes under frameworks such as FDA 21 CFR Parts 11, 820 and 812, EU MDR/IVDR, ISO 13485, ISO 14971 and ISO 14155. The software is a tool: it does not replace your quality system, your regulatory judgement or your legal obligations.

You remain the regulated entity. You are responsible for validating the Applications for your intended use, for your own procedures, for the accuracy and completeness of the records you enter, and for any submission, report or decision you make using them.

We publish validation packs (URS, IQ, OQ, PQ) and change records to support your validation activity. Reviewing and accepting that evidence within your own quality system is your responsibility.

6. Your data

You own the data your organisation puts into the Applications. We process it to provide the service, and in accordance with the privacy policy and, where applicable, a data processing agreement and HIPAA business associate agreement.

Records in regulated modules are append-only: superseded content is retained with its audit trail rather than deleted, so that record integrity requirements are met.

On termination you may export your data. After the retention window stated in your agreement, we delete or anonymise it unless a legal hold or statutory retention period applies.

7. Availability, changes and support

We aim to keep the Applications available continuously and carry out maintenance with notice where practicable. Availability commitments, if any, are those in your written subscription or enterprise agreement.

We improve the Applications continuously. We will not remove a materially relied-upon regulated capability from a paid plan during a subscription term without notice and a comparable replacement.

8. Intellectual property

Qevatrix and its licensors own the Applications, their content, templates, vocabularies and branding. You receive a non-exclusive, non-transferable right to use them during your subscription. Nothing here transfers ownership of our software to you, or of your data to us.

9. Disclaimers and liability

Except as expressly stated, the Applications are provided without warranties of any kind, including fitness for a particular regulatory purpose. Qevatrix does not provide legal, regulatory or medical advice.

To the maximum extent permitted by law, neither party is liable for indirect or consequential loss, and our total aggregate liability arising out of or in connection with the Applications is limited to the fees you paid in the twelve months before the event giving rise to the claim.

Nothing in these terms limits liability that cannot lawfully be limited, including for death or personal injury caused by negligence or for fraud.

10. Termination

Either party may terminate for material breach that is not remedied within 30 days of written notice. You may stop using the Applications at any time; cancellation of billing follows section 3.

On termination your access ends, and data handling follows section 6.

11. Governing law and contact

These terms are governed by the laws stated in your subscription or enterprise agreement; in the absence of such a statement, by the laws of the State of Delaware, United States, without regard to conflict-of-law rules.

Questions about these terms: qevatrix@qevatrix.com.