Hello!
We are a contract manufacturer for medical implant companies. I'm trying to implement ISO 13485 as well as 9001. Does anbody have any suggestions as to how to implement a risk management policy as a contract manufacturer that does not make a finished product?
My understanding is that we don't need to consider nearly as much information as a finished product supplier. We manufacture unfinished inactive orthopaedic implants.
If anyone has an example of what they have done that would be fantastic.
Thanks!
Jim

Hello!
We are a contract manufacturer for medical implant companies. I'm trying to implement ISO 13485 as well as 9001. Does anbody have any suggestions as to how to implement a risk management policy as a contract manufacturer that does not make a finished product?
My understanding is that we don't need to consider nearly as much information as a finished product supplier. We manufacture unfinished inactive orthopaedic implants.
If anyone has an example of what they have done that would be fantastic.
Thanks!
Jim
You are not the design owner as I understand, if you call yourself as a Contract manufacturer. The design owner hence in this case would have made a complete risk management document and you should be taking this as input into your risk management process and link all your manufacturing processes and controls and continue maintaining your established risk management. Your knowledge about the intended use of the finished device must be suitably acquired and applied into your risk management approach. Please be sure that you are responsible to establish documented requirements for risk management THROUGHOUT YOUR PRODUCT REALIZATION. Good luck.....

Dear Mr. Jim

It was nice to hear that as a medical devices contract manufacture is going to implement ISO 13485. Hope that you already made an agreement between contract manufacturer and design owner. Clearly define that who is responsibility to do the risk management activities during manufacturing. If contract manufacture is responsible, you suppose to follow ISO 14971:2007 (Medical devices -- Application of risk management to medical devices). Analyze, evaluate, control the risk during raw material receipt, manufacturing and up to delivery of the product to your designer. ISO 14971:2007 is mandatory to implement and part of your ISO 13485:2003 per clause 7.1. Also, get mandatory procedures from your designer such as infrastructure/ work environment procedure and follow the same.

Regards
Subbu
India.

There's been lots of recent discussion on this very point, you can use the search function to find them, however here (http://elsmar.com/Forums/showthread.php?t=33028) are a couple (http://elsmar.com/Forums/showthread.php?t=33226) to get you started.