Terms of request and risk management

Terms of request and risk management (v1.0, placeholder)

This document is a placeholder pending legal review.

1. Clinical responsibility. The requesting clinician confirms the clinical indication, the anatomy described and the imaging supplied are correct and complete.
2. Design input. A request is a regulated design input under ISO 13485:2016 §7.3. Nothing is manufactured until the design review file is approved by the clinician.
3. Standards acknowledged. 21 CFR Part 820, IEC 62304, ISO 13485, ISO 14971, MDD 93/42/EEC Annex II §3, and applicable FDA guidance.
4. Risk management. Risk is managed per SOP-15 (ISO 14971). A residual-risk summary accompanies the device file.
5. Changes. Change requests after submission generate an FM-03 record and may extend the lead time.
6. Records. Request records are retained for at least five years.
7. Billing. Institutional billing only. Quotes are issued per request; no card payment is taken on this platform.