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Evidence for Product realization

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Guest user Created:   Oct 04, 2019 Last commented:   Oct 08, 2019

Evidence for Product realization

We do not manufacturer medical devices/equipment, but we do service and repair them. We are looking to get ISO13485 certified as this will help with being compliant hopefully to the new MDR coming out in May 2020. Section 7 of ISO13485 is product realization. As we do not manufacturer but service, do we still need to provide evidence for this section?

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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 Oct 08, 2019

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.“

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Oct 04, 2019

Oct 08, 2019