Requirements for medical device implant

If you are asking what requirements are applicable for implantable medical device, here they are:

Most of the implantable devices need to be sterile, then requirements 7.5.5 Particular requirements for sterile medical devices and 7.5.7 Particular requirements for validation of processes for sterilization and sterile barrier systems are applicableImplantable medical devices do not need installation and service so requirements 7.5.3 Installation activities and 7.5.4 Servicing activities are not applicable

All other requirements are applicable.

For more information on what is ISO 13485, please see the following articles:

• What is ISO 13485? - https://advisera.com/13485academy/what-is-iso-13485/
• Six key benefits of ISO 13485 implementation - https://advisera.com/13485academy/knowledgebase/six-key-benefits-of-iso-13485-implementation/
• Checklist of ISO 13485 implementation and certification steps - https://advisera.com/13485academy/knowledgebase/checklist-of-iso-13485-implementation-and-certification-steps/