Applicability of Risk Management for Medical Devices - ISO 14971:2000

I

issmileplz

#11
Risk Analysis for other areas

I trully appreciate all your responses and thank you. However one main question is open and that is: Is risk analysis, evaluation and control of risks associated with changes as a result of deviations, non conformances, rework and or corrective action required. How do you folk handle the above. We are still discussing this issue and some collars in manufacturing are getting "Hot". My take: risk management/ analysis is for the life of the product, including all changes that would effect form, fit, or function and be a potential safety problem for the Patient. Would appreciate any inputs. Thanks in advance.
 
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C

Cathy

#12
Yes, you need to include a review of any design change, modification, upgrade in material, - anything that it changed about the product from the original design and risk analysis.

You need to do a risk analysis to prove it is safe and you have covered all possible risks.

If you think the change is insignificant, you still need to review the original analysis and make a note to file about the change.
 
Z

_zep_

#13
Risk Management (during Product Realization): What do you do to reduce risk?
Inspect and test to begin with, right?

qualify and monitor suppliers
you have receiving, in process and final inspection,
plus procedures for control of nonconformances
training

and you document that rework was evaluated and has no adverse effects
and concessions do not violate any regulatory standards, etc.
 
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W

wrodnigg

#15
EN ISO 1441 will be withdrawn by April 2004, so one will have to follow EN ISO 14971 for risk management of medical devices (especially CE marked ones).
 
C

calimar75

#16
Hello:
I have a bit of a dilemma. We have a quality system in place which I thought was compliance to ISO 13485:2003. I have stepped into the position as the Management Representative and after our stage 1 audit of our procedures it has been determined that we do not have a risk management procedure. The audit is next week and I am scrambling to develop a procedure. I saw that someone had some form templates that were incredibly helpful, but does anyone have an actual procedure from which I could work from. Scope, procedure etc.? Thanks.
 
H

Hello - 2006

#17
calimar75 said:
Hello:
I have a bit of a dilemma. We have a quality system in place which I thought was compliance to ISO 13485:2003. I have stepped into the position as the Management Representative and after our stage 1 audit of our procedures it has been determined that we do not have a risk management procedure. The audit is next week and I am scrambling to develop a procedure. I saw that someone had some form templates that were incredibly helpful, but does anyone have an actual procedure from which I could work from. Scope, procedure etc.? Thanks.
Hi Calimar75, my company has just gone through the compliance audit last week and was recommended for the certification. We do not establish any procedure but we have a Risk Management Manual instead.
 

Attachments

Q

Quality First1

#20
I will add my tup'pens worth (tup'pens= olde English money!)

The way I understand this updated risk management standard is that it you just do it once you use it when you change and review the product or product family. I am currently working through updating our risk analysis fom the previous standard. And I think one of the biggest areas to remember is that it it no longer a risk analysis it is RISK MANAGEMENT of the product or product family.

Not only do you need to initially assess the risks and justify them and any control, you need to review these with complaint history and possible design changes. To achieve this I have put a procedure together with all required docuemtation. It is difficult to explain but I attached the documents that I use.

What I have done is Identified the product
Planned the risk management
Assessed all known risks
Implemented additional controls where neccessary
wrote a risk management report for each family.

Even design change note has a section for risk review. This is carried out by me and I sign it off. If I haven't reviewed the risk and something happened....on my head be it. So with this in mind, I ensure my department review all changes thoroughly. It is the same with complaint investigation - I add a note to file about the product.

All risk files are fully reviewed every 6-12 months to ensure it is up to date.

Maybe this is a bit much but to me patient safety is much more importment than whether I can be bothered to take 5 minutes to check or updaye a file.

Thank you

Regards
 
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