Re: "Design Philosophy" - Iran Medical Device Registration
we have just found this application document for Iran with guidance notes, it contains info about the design philosophy that was asked back in August and other useful guidance.
Design Philosophy :
This section requests a description of the features that enable the device to be used for the medical conditions and purposes for which it is manufactured, sold or represented by the manufacturer. To satisfy this requirement, a brief description of the design philosophy and performance specifications for the device should be provided, linking them to the claimed indications for use. References and comparisons with appropriate previous versions or generations of the device should be presented. A tabular format is preferred for this comparison.
In the event that the use of the device is self-evident to the intended user, the customary or most frequent conditions or uses of the device should be summarized. This section should include an overview of the purposes and principles of operation for the device and a summary of the method of its use and operation, unless these instructions are not required for the
safe, effective use of the device. Details on the strength of materials and the accuracy, sensitivity and specificity of the device should also be supplied.
The physical aspects of the device, including packaging, operational capabilities and the processing of inputs and the resultant outputs, must be provided. This should include a summary comparison of the design input parameters (operation specifications) with the resultant performance specifications (design output characteristics).
hope this helps