Medical Device Safety Assurance Case Reports

R

rjmeader

#1
Hi,

Does anyone have experience with Safety Assurance Case Reports as required for some medical devices (such as infusion pumps)? If so, who in your organization has responsibility for leading this effort? R&D, Quality, other? Thanks.
 
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Marcelo

Inactive Registered Visitor
#2
Re: Safety Assurance Case Reports

Safety assurance cases are another way to show that you manage risks - meaning, they are part of risk management. Both are expected to be performed (and be the responsibility of) by a multifunctional team.
 
R

rjmeader

#3
Re: Safety Assurance Case Reports

Totally agree. But who really leads the effort (has "responsibility")? There has to be "ownership" by one function/individual otherwise it will likely flounder.
 

Marcelo

Inactive Registered Visitor
#4
Re: Safety Assurance Case Reports

Well, that?s a little more difficult.

In my opinion, it would have to be with the risk manager, but most manufacturers still do not have that role.

Anyway, it still should be the leader of the risk management team, so whatever function you put as the head of that team, it should be it. In my opinion, it would need to be someone from R&D (lot?s of manufacturer put this into quality but really risk management has nothing to do with quality).
 
Last edited:
R

rjmeader

#5
Thanks,

Again, totally agree. Unfortunately in some small medical device companies it just seems to fall to whomever picks up the baton and runs with it. R&D may not have the background, skills or motivation to take it on. Quality may be the next logical choice. If neither picks up the baton then Regulatory may somehow fee obligated to do something as ultimately they have to develop a submission.

Wonder what others think.
 

yodon

Staff member
Super Moderator
#6
Marcelo is right (as usual) and there's no 'guidance' on who should lead. Really (as with every role), it boils down to who has the skills (experience / training) to lead.

It's a substantial amount of work to build the assurance case so don't think someone can pick it up and knock it out in a few hours. And, as Marcelo points out, you'll want participation from stakeholders (it can't be done in isolation).

One approach is to outsource the leadership role to someone who does have the experience. Contracting someone with a few notches in their belt may be cheaper in the long run as they will know how to optimize the process.
 
R

rjmeader

#7
Thanks Yodon,

Yes it is a tremendous amount of work. I have done it wearing the Regulatory/Quality hat. Now as a consultant it is interesting to see how others are handling this. Very company has to find out what works best for them. Hopefully they have at least one person that steps up to the plate. Its important to have that ownership that a contractor may not realistically be able to provde.
 
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