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Post Market Surveillance SOP - Word Version

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C

claireyvb

#2
Hi Steve,

A great SOP...just out of interest how was it received in your surveillance audit? I have go to implement a "more proactive" PMS system so would be interested in your experience.

many thanks

C
 
S

SteveK

#3
Hi Claire,

Just had my annual audit this week - no NCs or observations! The auditor went through all the procedures, so I must be doing something right!

Thanks for the input.

Steve
 
B

bensnow

#6
Hi Steve

The SOP looks good.
I've got a question for you, excuse my ignorance is it normally the case that the quality manager is the responsible person for PMS?

Any thoughts gratefully appreciated- thanks in advance.

Cheers
B
 

Ajit Basrur

Staff member
Admin
#7
Hi Steve

The SOP looks good.
I've got a question for you, excuse my ignorance is it normally the case that the quality manager is the responsible person for PMS?

Any thoughts gratefully appreciated- thanks in advance.

Cheers
B
Hi bensnow,

Welcome to the Cove :bigwave:

In most organizations, yes, its the Quality Manager responsible for PMS.
 
S

SteveK

#8
Hi Steve

The SOP looks good.
I've got a question for you, excuse my ignorance is it normally the case that the quality manager is the responsible person for PMS?

Any thoughts gratefully appreciated- thanks in advance.

Cheers
B
Hi B,

Welcome also!

As Ajit rightly says I also believe this will be the situation in the majority of cases (I guess it depends on the size of the organisation – delegation to juniors for data gathering etc). Ultimately it will be the Quality (Assurance) Manager who will be the person liaising with the external auditor to show compliance i.e. that PMS is/has been conducted, so he/she will have the overall control IMO.

Steve
 
N

nashax

#9
Afternoon Steve,
we are new to medical devices and have just gone through our initial ISO13485 site registration audit. We have no post market surveillance SOP and have been told we need both reactive and proactive surveillance in the SOP. What aspects do you cover for proactive vigilance
Andrea
 
S

SteveK

#10
Hi Andrea,

Sorry about the delay in response - been on my hols. The main proactive vigilance (as indicated in my SOP) is monitoring alerts, recalls etc - especially as they relate to yours or a similar product. I log the number of overall incidents each month (MAUDE, MHRA etc) on a spreadsheet. I also record anything in more detail on related products. If I find a new hazard I can then update my risk management section of the TF and/or update my Clinical Evaluation section of the TF. This way you can physically show your proactive activities to your NB. Also your proactive vigalance activities are how you deal with complaints (e.g. speed of response), dealing with 'incidents' (ouch!), continuing literature reviews, sales feedback (e.g. reorders) etc. You can also show a NB your emails from e.g. MHRA who give you automatic weekly/daily info on Field Safety Notices, Alerts etc and also include various publishing houses e.g. AdvaMed SmartBrief who give industry updates on a regular basis.

I hope this helps.

Steve
 
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