Your company is not a manufacturer. Who should monitor the process?

When we come to ISO 13485, we noticed that there are a few things that should be clarified.

So, you want to produce a certain medical device, but your company has no conditions for such a thing, so what do you do?  Well, there are companies that exist exactly for needs like this.

They will provide you engineering services, engineering staff that controls the process, manage the life cycle of the product, and strive to improve product quality and lower production costs. They can even kit, package and ship your product for you.

As an owner of a medical device, but not manufacturer, you should be aware, that even if they are making your product, you’re the one that has responsibility for it. So, you are the owner.

In International standard ISO 13485:2016, it says: “The process required by this International Standard that is applicable to the organization, but is not performed by the organization are the responsibility of the organization and are accounted for in the organization’s quality management system by monitoring, maintaining, and controlling the processes”.

Basically, it says, you are still responsible for everything that is related to your medical device.

What is your part if they do almost all of it?

It goes like this: as long as your company name on the product, you are known as the “legal manufacturer” in the eyes of regulatory agencies. Being ultimately responsible for your quality system from a legal stand of point takes special caution about letting your manufacturer handling regulatory compliance.

You might be interested in this article as well.

When an organization chooses to outsource manufacturing, the process control criteria should have been defined and transposed into requirements for the supplier to comply with. Evidence of compliance to such defined requirements should be obtained from the organization providing the outsourced activity.

Your company needs to be constantly evaluating and monitoring their (manufacturer) system, to ensure it is effective and functioning as intended because you don’t want to find yourself in a position that you failed an audit by letting contract manufacturer taking care of compliance requirements.

Be aware, when working with an outsourced manufacturer, for your own good you should do routine audits, having management reviewal with them, checking on how they handling product issues, such as non-conformances, and especially to ensure to get your approval before they make any changes to your device.

Practically, you want to work closely as much as possible with the manufacturer you hired, to stay on top of the quality issues.

Keep in mind, to ensure everything is synced with your quality system you need to be involved in every step of the process and maintain your records.

Don’t forget!

It’s not an acceptable risk to take or do anything less.

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One reply to “Your company is not a manufacturer. Who should monitor the process?”

  1. Will says:

    I am not sure that is completely true. If you are a manufacturer, you need to have some obligations and to be responsible for your work.
    I expect more answers on this topic:

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