Terms of request and risk management

Terms of request and risk management

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.