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Using certified contract manufacturer impact

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Guest user Created:   Mar 04, 2021 Last commented:   Mar 08, 2021

Using certified contract manufacturer impact

We are set to produce our medical device through a contract manufacturer who holds ISO 13485 and ISO 9001 certifications. How does our use of a certified contract manufacturer impact what is required of our company regarding MDR / CE Mark? 

 

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Kristina Zvonar Brkić Mar 08, 2021

If you a legal manufacturer and want to put a medical device under your name, then you are also obliged to be certified according to ISO 13485. The contract manufacturer is your outsourced process and you need to have a proper quality agreement with them in accordance with the requirement 4.1.5 from the ISO 13485.2016. This quality agreement is supposed to cover mutual responsibilities, but also what kind of control you will have over them. Usually, the following are control measures:

Supplier's audit – you will perform supplier audit over them in a periodicity which will be risk-based the need for the outsourced company to notify you if it receives any complaint about similar products mutual communication in resolving complaints and inconsistencies - defined time required to respond to inquiries and clarifications

Considering the MDR /CE mark, again if you are a legal manufacturer and want to put a medical device under your name, then it is your responsibility to prepare the technical file in accordance with the Annex II and Annex III of MDR. Be prepared that when the notified body will come for your MDR audit they will also go to the audit of the outsourced certified company.  

For more information, see: 

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Mar 04, 2021

Mar 08, 2021