Evidence for Product realization

Yes, you do need to provide evidence for this section 7, but only for those sections that are applicable for your company. Therefore, for each section that is not applicable for you, you can state that in your Quality manual. For example, section 7.5.2 Cleanliness of product is probably not applicable, then 7.5.5 Particular requirements for sterile medical devices, 7.5.7 Particular requirements for validation of processes for sterilization and sterile barrier systems, and 7.5.9.2 Particular requirements for implantable medical devices. For each of these sections you need to provide justification for why it is not applicable. For example, you can state „7.5.2 Cleanliness of product is not applicable since we do not produce any product“ or „7.5.5 Particular requirements for sterile medical devices is not applicable since we do not produce sterile medical devices.“