Common use of Design Reviews Clause in Contracts

Design Reviews. The following Technical Design Reviews (TDR) will be completed by Cordis for the carotid stent delivery system catalogs with 65cm length project: • Design Review I: Combined Design Input, Concept Selection and Planning & Design Output Technical Design Review (Prototypes testing completed) • Design Review II: Combined Verification/Validation and Design and Technology Transfer Technical Design Review (DV/PPQ Report approved) Evidence of completion of Design Review I and Design Review II will be document as required per Cordis Quality System, A Clinical Readiness Design Review is responsibility of SRM and will not be documented in the Cordis Quality System,

Design Reviews. The following Technical Design Reviews (TDR) will be completed by Cordis for the carotid stent delivery system catalogs with 6557cm length project: • Design Review I: Combined Design Input, Concept Selection and Planning & Design Output Technical Design Review (Prototypes testing completed) • Design Review II: Combined Verification/Validation and Design and Technology Transfer Technical Design Review (DV/PPQ PQ Report approved) Evidence of completion of Design Review I and Design Review II these design reviews will be document documented as required per Cordis Quality System, . A Clinical Readiness Design Review is responsibility of SRM and will not be documented in the Cordis Quality System,.