Determining the Impact of ISO 13485

J

Jamessagen

#1
I just started working for a contract manufacturing company that just started producing small diagnostic medical devices (class II). they have been asked by the owner of the device to participate in the design and engineering of the next generation of the device. but their ISO scope excluded design, I am updating the scope but in looking at the process they have in place, I am curious how a contract Manufacturer will perform a hazard ID or risk analysis of the device which will be put through the 510k process by the owning company (not us). My experience has been that the owning company would provide an initial hazard ID, do we as the manufacturer have any input into that process my first inclination is no as we are not deciding its us just implementing a request?.

My experience has been mainly as the OEM QA now I am the sub contractor QA and how do I integrate customer notification in bug testing or design problem solving? does that need to be documented in both systems?

we will be the manufacturer of the device should we have a full technical file at our disposal? what regulatory files?
 
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R

rgmain

#2
You should be able to provide all traceability records including inspection & test as applicable, but your customer still owns the product and should be the one with the burden of the 510k & compliance unless you have taken this on in your scope of supply I.E Purchase Order Requirements
 
M

MIREGMGR

#3
they have been asked by the owner of the device to participate in the design and engineering of the next generation of the device. but their ISO scope excluded design, I am updating the scope but in looking at the process they have in place, I am curious how a contract Manufacturer will perform a hazard ID or risk analysis of the device which will be put through the 510k process by the owning company (not us). My experience has been that the owning company would provide an initial hazard ID, do we as the manufacturer have any input into that process my first inclination is no as we are not deciding its us just implementing a request?.

My experience has been mainly as the OEM QA now I am the sub contractor QA and how do I integrate customer notification in bug testing or design problem solving? does that need to be documented in both systems?

we will be the manufacturer of the device should we have a full technical file at our disposal? what regulatory files?
Please clarify for us whether your contractural agreement with the "owning company" defines your company as the non-regulatorily-responsible Contract Manufacturer, or the regulatorily-responsible Manufacturer.

The Manufacturer is solely and completely responsible for all aspects of compliance, whether they do the necessary compliance work themselves or arrange for another party, such as the Contract Manufacturer, to do some or all of that compliance work for them.

To avoid confusion, my preference is to use the term "maker" to describe the company that physically fabricates the product. This then allows the Manufacturer and Contract Manufacturer terms to be used only in regard to regulatory responsibility, and keeps everyone on the same page in terms of understanding the situation.
 

Ronen E

Problem Solver
Staff member
Moderator
#4
I just started working for a contract manufacturing company that just started producing small diagnostic medical devices (class II). they have been asked by the owner of the device to participate in the design and engineering of the next generation of the device. but their ISO scope excluded design, I am updating the scope but in looking at the process they have in place, I am curious how a contract Manufacturer will perform a hazard ID or risk analysis of the device which will be put through the 510k process by the owning company (not us). My experience has been that the owning company would provide an initial hazard ID, do we as the manufacturer have any input into that process my first inclination is no as we are not deciding its us just implementing a request?.

My experience has been mainly as the OEM QA now I am the sub contractor QA and how do I integrate customer notification in bug testing or design problem solving? does that need to be documented in both systems?

we will be the manufacturer of the device should we have a full technical file at our disposal? what regulatory files?
Hi,

First of all good luck in your new role.

Second, there are at least 3 aspects this issue could and should be viewed from:

1. US regulation and FDA expectations.
2. ISO 13485, within the scope of certification.
3. Spelled out contractual obligations towards your customer.

Each of these layers could lead to different answers to some or all of your questions.

The first layer is very simple - you have to do what you have to do (just a matter of sorting out what it is).

The second is semi-rigid - you have to follow the standard, but it is up to your management to decide which parts you exclude (e.g. 7.3).

The third could be anything. Negotiate and then implement.

Cheers,
Ronen.

P.S. Although some overlapping possible in requirements, I would view the 3 aspects as independent - analyse your obligations by each separately, then combine to avoid redundancy.
 

jkuil

Quite Involved in Discussions
#5
I just started working for a contract manufacturing company that just started producing small diagnostic medical devices (class II). they have been asked by the owner of the device to participate in the design and engineering of the next generation of the device. but their ISO scope excluded design, I am updating the scope but in looking at the process they have in place, I am curious how a contract Manufacturer will perform a hazard ID or risk analysis of the device which will be put through the 510k process by the owning company (not us). My experience has been that the owning company would provide an initial hazard ID, do we as the manufacturer have any input into that process my first inclination is no as we are not deciding its us just implementing a request?.

My experience has been mainly as the OEM QA now I am the sub contractor QA and how do I integrate customer notification in bug testing or design problem solving? does that need to be documented in both systems?

we will be the manufacturer of the device should we have a full technical file at our disposal? what regulatory files?
The owning company is the "legal manufacturer" or the "labeled manufacturer" that will put the device on the market. The legal manufacturer retains the full responsibility of the performance of the device on the market. For that reason none of the ISO 13485 paragraphs can be excluded by the legal manufacturer. The activities involved with the design of the device may be outsourced, but not the final responsibility. The legal manufacturer will be held responsible when a badly designed device is put to the market. The legal manufacturer must implement a level of control over the contract designer (or contract manufacturer in case of outsourced production activities).
 
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