Transition Engineering
Development is followed by a transition to production readiness. Process parameters are finalized and tested. ATEK Medical focuses on establishing accurate and efficient processes to produce a consistent product that will meet the customers specifications. The transition phase applies to any new product implementation for manufacture of a new, re-designed, or transfer of an existing device whether developed internally or for customers that have contracted ATEK Medical for such projects.
The following processes are included in this phase:
- Procure all tooling and manufacturing equipment
- Qualify all tooling (mold qual), equipment, and fixtures
- Procure all components
- Design validation testing
- Process validation testing
- Execute and complete quality & regulatory requirements
The ATEK Medical product launch procedures and templates within the implementation phase provide the processes for completing the supply chain and manufacturing requirements, ensuring through completion and documentation of validation activities that the finished device requirements are met.
Key Elements within Implementation
