What can I expect to be charged for annual PMS reports?

stevemds

Registered
Hello. I am a small manufacturer and I'm in the market for a regulatory consultant who can take care of some tasks including post-market surveillance and creation of reports instead of having to do it in-house.

We have a few devices ranging from low risk to higher risk. I'm posting to ask about pricing for a consultant to create PMS reports for these different devices and what factors may affect that pricing. I'd like to figure out what to expect to be charged before venturing into the market for this. Generally we need annual reports but are also interested in ongoing surveillance, either monthly or quarterly.

If anybody can shed some light on this topic and help me set expectations, it would be greatly appreciated!
 

StepPCHen

Involved In Discussions
Hi Stevemds,

The costs for consultants can greatly vary and can quickly get very expensive, and this will depend on the nature of the device and its complexity. How long has the device been on the market? Have there been adverse events? Recalls, Harms, FSNs, complaints? Also considered would be your risk management procedures and processes.

I was in a similar position 3 years ago and decided to do it myself. It has since been looked at by our NB and they accepted everything without any kick back.

Also, your higher risk class devices would need more than a PMS report, depending on the device class you will need a PSUR.
 

Raisin picker

Quite Involved in Discussions
PMS reports shouldn't be that hard, since your device is class I. For class IIa/b and class III, you'd need a PSUR.
And don't for get PMCF. You will need a PMCF plan and report, unless you got a good justification.
 

Vetty007

Involved In Discussions
For me, as a consultant, the literature search is the most time consuming and thus expensiest part, but also depends on the device. I always charge less, than I spend time for this part as it usually easily sums up for a lot of hours, for which I am very sorry for the manufacturers requiring to do this search on a regular basis. If you have a lot of search results, that quickly is the case due to 2 databases needed, and you will need to read several papers with several pages, you can easily spend 0,5-1 hrs. per publication for reading, rateing and summarizing the important aspects not given in the abstract. Also you need to organize the publications, also the ones not important, but also indicating, why they are not relevant. Thus its simply a lot of work with easily ending up with 60 hrs of work. For me that is an incredible high amount of work, but in detail 30 min. for one publication isn't that much, but in total end sup with this high amount of hrs..... For the other parts of the PSUR, its only 2-3 (5) days of work, but this can certainly vary greatly depending on the device
 
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