Development

Once an idea or concept is ready to be transferred to a specification, using sound internal product launch procedures, ATEK can successfully progress an idea and document the Design History Files per design control requirements. ATEK Medical can assist or lead this business step.

The following processes are included in this phase:

• Maintain input/output matrix, DFMEA, and CAD models/component and assembly drawings
• Finalize performance specification based on design inputs
• Create design verification/validation plan from input/output matrix
• Define preliminary manufacturing process, PFMEA, and documentation
• Define final BOM, suppliers, and component costs
• Initiate regulatory requirements
• Design verification testing on engineering samples if necessary

The ATEK Medical product launch procedures and templates within the Development phase provide the processes for completing the device design and identifying and documenting the supply chain and manufacturing resources required.

Key Elements within Development