rmf180

Involved In Discussions
#1
I work for a medical device component supplier who is now being asked to register as a contract manufacturer for a specific device. As we have been supplying components for many years, we comply with most of 21 CFR 820. The primary exception is design. In this case, we still will not be design responsible, but we do design tooling for the components and tooling used for assembly of the device.

I am concerned about the QSIT requirements regarding design controls as our tooling function has traditionally been excluded from most requirements because ISO auditors focus on the end product. What level of design controls are typically expected by FDA inspectors related to tooling and assembly equipment?
 

yodon

Staff member
Super Moderator
#2
Can't say I've ever seen tooling design come under consideration regarding 820. The DHF (where all the design artifacts go) is product-based.

Of course, there would be an expectation to demonstrate that the tooling is designed and performs as intended but this falls under Production and Process Controls.
 

Ajit Basrur

Staff member
Admin
#3
Don is right. Your customer is responsible for demonstrating the fulfillment of the design control requirements. The contract manufacturer may be required to show compliance that the tool was built per customer requirements.
 

somashekar

Staff member
Super Moderator
#4
I work for a medical device component supplier who is now being asked to register as a contract manufacturer for a specific device. As we have been supplying components for many years, we comply with most of 21 CFR 820. The primary exception is design. In this case, we still will not be design responsible, but we do design tooling for the components and tooling used for assembly of the device.

I am concerned about the QSIT requirements regarding design controls as our tooling function has traditionally been excluded from most requirements because ISO auditors focus on the end product. What level of design controls are typically expected by FDA inspectors related to tooling and assembly equipment?
Who is asking ?
What is the component ?
Is that component a medical device ?
 
#5
Keep in mind "design" transfer, as in "to" production. You'll be responsible for process development aspect traditionally as CM (bare minimum the validation or verification of such), and any correlation with the design of the device (Risk to product, Risk to end user, etc...) that may adversely be impacted. Use a robust technical agreement which identifies your responsibility, and the clients IP, but for all intents and purposes create an I/O matrix (even if it is simply production/assembly activities, and testing) and maintain a more robust record than you think you will need... for posterity. Just my two cents.
 

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