Each medical device development process is conducted under OTI design control, whether new, or related to modifying an existing product, must comply with the following five phase design control process:
- Phase 0:
Product Definition - Phase 1:
Concept & Feasibility Demonstration - Phase 2:
Design Development / Verification & Validation - Phase 3:
Final Validation /
Product Launch Preparation - Phase 4:
Product Launch & Post-Launch Assessment
Each phase mandates specific inputs and outputs designed to promote consistent design control for all projects. This provides a road map for the design team to follow.
It is possible to start a particular phase before a prior phase is completed if the proper input requirements are ready. This design control process does not allow for the completion of a phase with a prior phase remaining uncompleted. It is the responsibility of the Program Manager to assure that activities are not started before proper inputs are in place.
OTI owns the responsibility for Phases 0- Phase 2. Phases 3 & 4 are generally maintained by the client with assistance from OTI.
go to Phase 0 »
or refer to our Phase-Gate Decision Process Chart »