Design History File
We can assist in all the phases of Design Control, from Design Input to Design Transfer, and we can help determine the needed documentation and level of detail to be included in the Design History File (DHF).
We know how toplan an effective development processand we can facilitate thisfrom start to end.
A clear specification of requirements is the basic for a robust device development process.
We know which documents must be generated incl. the required level of detail,for justifying the design of the device.
Design Verification & Validation
A statistically based testing of functionality and usability is the key for an effective authority approval.
We have a solid experience in ensuring an effective transfer from development to production.