ISO 14971 Determination of Competent Persons

[maxalmill]

All, I'm relatively new to MD. We know that ISO 14971 requires us to assign competent personnel to perform risk management activities, meaning people who know how the MD is constructed, how the MD works, how the MD is produced, how the MD is actually used, how to apply the process. What is industry practice for the departments that sign in the RMF? It appears to me at a minimum Regulatory, Quality and Engineering, but I don't want to miss anyone who should be included by industry practice.

 

[yodon]

You're definitely on the right track. There may be specific aspects where you need specialists; e.g., if you're considering electrical issues, you need EEs, software needs software engineers, if you're considering the usability aspects then human factors engineers should be involved, etc. Realize that not everyone on the team has to sign off on everything.

Here are some other considerations for involvement (not necessarily for signing):

• You absolutely need someone that has the clinical expertise to articulate the clinical effects. This is an area, from my experience, that reviewers are scrutinizing more closely. (historically, it was not uncommon just to have engineering define effects.)
• You should have someone that is an expert in the (14971) process to ensure it's implemented properly.
• Controls need to be verified and/or validated so having someone from test to ensure they're written properly is a good idea

I typically list the ROLES (not individuals) that will be used throughout the process in the RM Plan. This dovetails with the requirement to define the assignment of responsibilities and authorities. That provides the 'roadmap' for who does what.

There's nothing prescriptive about who signs off on anything in particular in the risk file. Because management is responsible for ensuring adequate and appropriate resources, for the individual risk acceptability policy, and for accepting the overall residual risk / benefit risk analysis I get them to sign off on the Plan and the Risk Report. They need to recognize they are ultimately responsible for what goes to the field. Since the conclusions regarding benefit-risk ratio is often in the risk report, I have the clinical expert sign off on that as well.

 

[somashekar]

All, I'm relatively new to MD. We know that ISO 14971 requires us to assign competent personnel to perform risk management activities, meaning people who know how the MD is constructed, how the MD works, how the MD is produced, how the MD is actually used, how to apply the process. What is industry practice for the departments that sign in the RMF? It appears to me at a minimum Regulatory, Quality and Engineering, but I don't want to miss anyone who should be included by industry practice.

Hi Maxalmill...look at how your organization can get associated with Doctors and Paramedics who are the users of similar devices. They will be able to give you a lot of inputs which can be considered. Big names in MD are associated with bigger hospitals, nevertheless, it depends upon your reach and contacts in your local area, with the help of your top management. yoden has detailed it very well above.....

 

[primavesvera]

• You should have someone that is an expert in the (14971) process to ensure it's implemented properly.

There are a lot of courses on this topic, does it really help you to make you the expert in Risk mgmt?
For example, I have some engineers in my team and they are really struggling to understand the concept of ISO14971 and it seems so difficult to translate some requirements to them. I was wondering if courses could actually help.

Btw, as somebody wrote, medical personnel is also a good way to include such particular opinion and point of view (this was the recommendation we got after the audit).

 

[Jean_B]

Not affiliated, but am a user of the book Safety Risk Management for Medical Devices - 1st Edition (elsevier.com) and have seen 2 of the courses by Bijan Elahi. If you have the time, he was working on a second edition covering the 2019 edition, but it isn't out yet.

They best approximate in a condensed timeframe which otherwise could only be gained by long arduous experience with success and failures and deep self-study of multiple materials. It doesn't cover everything in the greatest level of detail, but does give you the framework to understand the purposes of the matters, the interactions and provides example of a workable setup.