A company can have implemented ISO 13485 only for the Desing and development. In that case, some requirements will be stated as „non-applicable“, like: 7.5.3 Installation activities, 7.5.4. Service activities, 7.5.5 Particular requirements for sterile medical devices, 7.5.7 Particular requirements for validation of processes for sterilization and sterile barrier systems. The main procedure, in that case, will be Desing and development, which will replace the procedure for production and service provision.
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