Medical Device Contract Manufacturer doesn't know ISO 14971 3.4 a) Life Cycle Phases

ISO 14971 3.4 a) says the RM plan should include "the life-cycle phases for which each element of the plan is applicable."

My company does contract manufacturing, and a combination of both contract engineering and contract manufacturing for medical devices. We do not market the devices and are not "The Manufacturer" of record.

How would I address "life-cycle phases" if this isn't my company's product? Doesn't "The Manufacturer" define those phases?

Possibly I need a real definition of what is meant by "life-cycle phases".

Re: Medical Device Contract Manufacturer doesn't know ISO 14971 3.4 a) Life Cycle Pha

Normally risk management is the responsibility of the Manufacturer, not the contract manufacturer/contract designer.

Perhaps your contract with the Manufacturer calls for you to perform this analysis for them. That's fine, but it doesn't change who is responsible for the work, and it doesn't change the fundamental need for the risk analysis to be done as if by the Manufacturer, taking into account the product's "life cycle phases" from their perspective...not yours.

Life cycle phases might encompass product planning; product design and development; product clinical evaluation; product release and regular marketing; product discontinuance but support until obsolete/exhausted. That of course would be adjusted depending on the nature of a given product.

Re: Medical Device Contract Manufacturer doesn't know ISO 14971 3.4 a) Life Cycle Pha

MIREGMGR said:

Normally risk management is the responsibility of the Manufacturer, not the contract manufacturer/contract designer.

Perhaps your contract with the Manufacturer calls for you to perform this analysis for them. That's fine, but it doesn't change who is responsible for the work, and it doesn't change the fundamental need for the risk analysis to be done as if by the Manufacturer, taking into account the product's "life cycle phases" from their perspective...not yours.

Click to expand...

I definitely agree with what is written above BUT.....

1) I am putting a ISO 14971 RM program in place to placate auditors who jump on me for not having a RM program during ISO 13485 audits. (I know, I know....not a good reason to implement RM.)

2) My customers don't have the manufacturing expertise so my company doing the RM from a manufacturing point makes more sense.

I have no choice on implementing an ISO 14971 RM system.
That is also my frustration with ISO 13485 and ISO 14971. They are both writtten from the perspective that you are The Manufacturer. I would love to see explicit callouts for subcontractor activities.

Re: Medical Device Contract Manufacturer doesn't know ISO 14971 3.4 a) Life Cycle Pha

RCW said:

1) I am putting a ISO 14971 RM program in place to placate auditors who jump on me for not having a RM program during ISO 13485 audits.

Click to expand...

Your company's own risk management requirements are in regard to those activities for which you are responsible.

2) My customers don't have the manufacturing expertise so my company doing the RM from a manufacturing point makes more sense.

Click to expand...

In regard to the products for which each of your customers is responsible, they also are responsible for the associated risk management...even if they contract with someone else, i.e. you, to do the work involved.

That is also my frustration with ISO 13485 and ISO 14971. They are both writtten from the perspective that you are The Manufacturer. I would love to see explicit callouts for subcontractor activities.

Click to expand...

They are written to be applied by the responsible party.