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Hi, I am new to the board, but I would appreciate any guidance on this issue. We are a contract manufacturer who makes components for medical device manufacturer. We are currently ISO 9001 certified, but we are in the process of obtaining a 13485 certification. However, I am struggling with the best way to implement the risk management aspect of the 13485 standard.
We do not design the product; we simply build based on our customers design specifications. Hence, it's difficult to have a risk manangement file on the product as ISO 14971 standard requires since we can assess component failure mode's impact to the patient/ end user. Would it be more appropriate to perform a process risk assessment with the failure mode being that product does not meet customer specification? Also, does anyone has any example procedures and/or templates that would help? Finally, I have read some of the older threads on this forum on the topic for contract manufacturer, yet none really addressed my concerns. Thus, I would appreciate any help you can provide.
Thanks
We do not design the product; we simply build based on our customers design specifications. Hence, it's difficult to have a risk manangement file on the product as ISO 14971 standard requires since we can assess component failure mode's impact to the patient/ end user. Would it be more appropriate to perform a process risk assessment with the failure mode being that product does not meet customer specification? Also, does anyone has any example procedures and/or templates that would help? Finally, I have read some of the older threads on this forum on the topic for contract manufacturer, yet none really addressed my concerns. Thus, I would appreciate any help you can provide.
Thanks