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ISO 13485 requirements for virtual IVD manufacturer

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Guest user Created:   Feb 17, 2021 Last commented:   Feb 18, 2021

ISO 13485 requirements for virtual IVD manufacturer

Hi there, I will like some advice on the ISO13485 requirements for a virtual IVD manufacturer which only designs the device?

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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Kristina Zvonar Brkić Feb 18, 2021

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:

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

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Feb 17, 2021

Feb 18, 2021