Risk Management Plan for a Class III Medical Device (Bone Void Filler)

[qualityneel]

Hi all,
First of all I would like to thank Elsmar forum for providing me valuable guidance at the initial phase of my QARA career.

Currently I am working on Risk Management for a class III medical device(bone void filler ) . I have got an insight in to the risk management activity thro' all your posts.

It will be very helpful to me if you guys could assist me with a Sample Risk management Plan .

I really appreciate it

[Randy]

Plan or matrix?

I forgot who, but someone here supplied the attached spreadsheet.

The 2nd attachment is more relevant to safety but could be tweaked maybe.

[Ensign Suder]

First let me say that the first attachment is amazing! Whoever put it together did a fantastic job, and I am very grateful to Randy for being willing to share it.

I haven't had a chance to go through the whole thing, but I couldn't find anything that addressed the original request for a Risk Management Plan. I think I may be looking for the same thing as Qualityneel, and that's why I jumped into the conversation.

14971 requires a risk management plan be developed. The standard is pretty clear on what's required, but even so I'm still unsure on how to proceed. I've been trying to get some ideas on how other people have addressed the need to get a better feel of what the plan is supposed ot look like. It would be especially helpful if anyone has a plan that's been scrutinized by either FDA or ISO and got a pass on it and are willing to share.

Thanks.

Ensign Suder

[Marcelo Antunes]

Just for curiosity´s sake, did you read Annex F of ISO 14971:2007 which detaisl the contents of the risk management plan?

Anyway, fo the six requirements, i think the most troublemsome one would be the first, scope, mainly in relation to definind each activity and "attaching" it to the device lifecycle phase.

If already not done, you must first define in a clear way the device life cycle, with enough detail fo fit the activites you´re planning. Then i think the best way is to use each requirement of the standard as an activity and dsitrtibute them in the life cycle, as needed. Some activities will have to de linked to more than timeframe (for example, if you discover a risk in post marketing survaillance you have to go though the risk management proccess all over again).

In general a ways of thinking of this plan is - when i´ll do what the standard requires?

[Ensign Suder]

Thanks for the reply. I've read Annex F and that's where some of my confusion comes from. It's always good to have the latititude to generate a document that makes sense and works for the specific situation it was developed for, and I'm sure that Annex F was written to allow as much latitude as possible.

However, a risk management plan is a document with an importance that can't be understated. It not only is supposed to identify and define the risk managemnt process and fufill a regulatory requirement, but could ultimately be used in court to defend (or condem) a company's actions toward risk remediation in regard to a particular product.

So its important to know when the plan is sufficient but, even with the guidance given in Annex F, there are still unanswered questions. I thought I'd check to see if there was anyone who would be willing to share a template or checklist they had used in development of their risk management plan that helped ensure that enough questions were asked. Barring that, I wondered if anyone could relate the process they used to develop a plan and whether their plan was deemed acceptable by the regulators/auditors.

Thanks,
Ensign Suder

[Roland Cooke]

If the bone filler contains (e.g.) an antimicrobial agent, there will be additional steps required to manage the risks of including a medicinal agent.

The regulatory pathway will also be different of course.