I have started to create the technical file for Medical device Class IIb product. Could anyone tell me what will be the content of the technical file?? I have confusion whether my technical file will consist of :
1. Does it contain all the procedure of the quality system ISO13485?
2. Does it consist of Product Validation, Process Validation and Software Validation report?
3. If I conduct the product validation then Do I need to do separate software validation process? Cause some of the users needs also consist of the software function.
1. Does it contain all the procedure of the quality system ISO13485?
2. Does it consist of Product Validation, Process Validation and Software Validation report?
3. If I conduct the product validation then Do I need to do separate software validation process? Cause some of the users needs also consist of the software function.