ISO 13485 requirements for virtual IVD manufacturer

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. 

For more information, please see the following article:

• How to manage design and development of medical devices according to ISO 13485:2016 https://advisera.com/13485academy/blog/2017/08/24/how-to-manage-design-and-development-of-medical-devices-according-to-iso-134852016/

You can see how we have prepared the Design and development procedure in our ISO 13485:2016 Documentation toolkit:

• Design and Development File https://advisera.com/13485academy/documentation/design-and-development-file-iso-13485-2016/
• ISO 13485:2016 Documentation Toolkit https://advisera.com/13485academy/iso-13485-documentation-toolkit/