Terms of service
The service
Medica provides software that helps your organisation produce, control and sign design-control documentation. Medica is not a notified body, a regulator or a consultancy: the content of your documents, the decisions recorded at gates and the submissions you make remain your responsibility.
Assist output
Text proposed by Medica Assist is labelled until a person accepts it. Accepting it is a decision you make and record; Medica makes no warranty that generated text is complete, correct or sufficient for any regulatory purpose.
Electronic signatures
By enrolling an authenticator you agree that signatures applied through it are the legally binding equivalent of your handwritten signature, as 21 CFR 11.100(c) requires, and you will certify this to the FDA where applicable. You are responsible for the security of your authenticator.
Records
The ledger is append-only. Medica will not edit or delete a ledger row at anyone’s request, including yours; voiding a signature is itself a recorded row.
Availability and support
Service levels, support hours and incident communication are set out in your order form. Medica publishes operational status at /legal/status.
Licensing
The service is licensed, not sold; cloud subscription or owner-operated instance, per your order form. No part of the software may be copied, reverse engineered or redistributed.
Contact
legal@medica.design