Your company is not a manufacturer. Who should monitor the process?
Small medical device companies and startups have a few things that should be clarified when producing their device. They want to produce a certain medical device, but their company has no conditions for such a thing. How to find a good manufacturer? Who should monitor the process? Who is responsible for production?
The outsourced manufacturer will provide you engineering services and engineering staff that controls the process. They can also 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, you should be aware that you’re the one that has responsibility for everything. 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.
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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.
Who should monitor the process?
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.
It’s not an acceptable risk to take or do anything less.