ISO 13485 Risk Management for Contract Manufacturer

[Roland Cooke]

I hasten to add:

a) those questions were off the top of my head!
b) I am not an orthopaedics product specialist
c) I am not a metallurgist

It may well be that the final customer is expert on all this stuff - that will make your client's job very easy. My point is that it is important (from an ethical standpoint, if nothing else), to not automatically assume that is indeed the case.

[cjssag]

In Reply to Parent Post by Roland Cooke

I hasten to add:

a) those questions were off the top of my head!
b) I am not an orthopaedics product specialist
c) I am not a metallurgist

It may well be that the final customer is expert on all this stuff - that will make your client's job very easy. My point is that it is important (from an ethical standpoint, if nothing else), to not automatically assume that is indeed the case.

I learned too many years ago that I assume at my own peril. I am not certain how to quantify what is or isn't ethical except to say I believe we are all obligated - standards notwithstanding - to give 110%, to always strive to do better, to never do that which we know is wrong or which we believe might be wrong: in essence to never do anything that will not pass the smell test.

My chief concern for my small clients, who are low on the medical device supply chain, is not the requirements of the standards. I/We can always learn how to do that which is required - thanks to folks like yourself. That part we can control.

What we cannot control is the "blood-in-the-water", litigious environment that surrounds this industry in the USA. My clients' only protection from this uncontrollable plague, aside from insurance, is that they are small(er) fish and do not present as rich a feast as do the OEM's.

I have been through major product litigation in the past where, after two years, we were dismissed from the suit and learned that insurance doesn't cover the disruption. It was as if management's time and attention were sucked into that black hole for the duration. Day to day business suffered from it while the business' progress was put on hold.

Being a conservative, old codger I suppose my clients'
"risk appetite" is far greater than mine.

[treesei]

"Only one of the parts can be considered an end product: it is intended for implant but the OEM does all the sterilization, packaging and labeling."

This puts this client under FDA regulation (if the part is used in US) or 13485 (if used in many other countries). The part is already a finished device per FDA definition. Hope the client has registered with the FDA if product is used in US.

Am I wrong?

[MIREGMGR]

I'm not sure of your intent with regard to the word "client", so let's use "contract manufacturer" for the company that does the machining.

Per http://www.fda.gov/cdrh/registration/whomust.html, a contract manufacturer that does not participate in marketing the product they manufacture, whether that product is a finished medical device (i.e. ready to market) or requires further manufacturing steps before it is ready to market (for instance, sterilization, packaging and/or labeling), is not required to register their establishment and not required to list (on the FDA DRLM website) the products they make.

The company that markets the finished product has primary responsibility for all aspects of manufacturing, and is expected to control that manufacturing through their contract with the contract manufacturer.

The company that markets the product has responsibility for premarket notification or approval, as applicable.

The company that markets the product has responsibility for post-market vigilance and any associated reporting requirements.

The contract manufacturer has co-responsibility for those aspects of the product creation process over which they have some degree of direct control, either practically or by contractural agreement. The contract manufacturer may be inspected if an inspection of the product marketer gives rise to questions regarding the manufacturing process, or if a field issue arises in regard to the product they make.