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Do medical device distributors and 3rd party logistics providers benefit from implementing ISO 13485 and MRD?

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Guest user Created:   Mar 10, 2023 Last commented:   Mar 10, 2023

Do medical device distributors and 3rd party logistics providers benefit from implementing ISO 13485 and MRD?

We are a 3PL. I understand that the ISO 13485 regulations were designed specifically for Medical Device manufacturers. However, do medical device distributors and 3rd party logistics providers benefit from implementing these standards? Additionally, can 3PLs be certified under ISO 13485?

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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 Mar 10, 2023

Yes, 3rd party logistics can be certified under ISO 13485. In the standard, in the Scope section is stated that this International Standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services. Such organizations can be involved in one or more life cycle stages, including design and development, production, storage and distribution, installation, or servicing of a medical device, and design and development or provision of associated activities (e.g. technical support). Therefore, 3PL can implement ISO 13485.   

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Mar 10, 2023

Mar 10, 2023