Post Market Surveillance SOP - Word Version

Elsmar Forum Sponsor
W

Woodray

#32
Hi,

Would you also have design and development templates so that I can then modify to customise it to my situation. It damn hard to start from scratch, thanks :deadhorse:
 
M

mmalik

#33
Hello Steve and others.
Great SOP!
Does anyone have this PMS SOP for the new EU MDR? I am also looking for SOPs for clinical investigation and CER.
Thanks for any help I can get.
 

Ronen E

Problem Solver
Staff member
Moderator
#35
Anyone interested in purchasing any MDR-compliant documents (SOPs, templates etc.) - please send me a message. These will be customised for your own org and device type(s). Implementation guidance/support may be included.

Have a nice day,
Ronen.
 
M

mmalik

#36
I have had a request to supply a Word version of the PMS SOP (previously pdf format) I attached to a previous post - so here it is!

Steve
Dear Steve - this is so great - many thanks indeed. Can I please ask, would it at all be possible for you to share with me your SOPs like this in Word for PMCF and Clinical Investigation too please? It would be a huge favour if you can.
 
M

mmalik

#37
Anyone interested in purchasing any MDR-compliant documents (SOPs, templates etc.) - please send me a message. These will be customised for your own org and device type(s). Implementation guidance/support may be included.

Have a nice day,
Ronen.
Hi Ronen
How much would it cost to buy MDR SOPs for PMS, PMCF, Clinical Evaluation and Clinical Investigation?
I also need PMS plan, and PMCF plan, CEP, CDP and CIP.
Finally, can I please ask who is the writer of these documents and their experience (and if this is being sold online to others too - which would be a plus point).
Thanks
 

Ronen E

Problem Solver
Staff member
Moderator
#38
Hi Ronen
How much would it cost to buy MDR SOPs for PMS, PMCF, Clinical Evaluation and Clinical Investigation?
I also need PMS plan, and PMCF plan, CEP, CDP and CIP.
Finally, can I please ask who is the writer of these documents and their experience (and if this is being sold online to others too - which would be a plus point).
Thanks
Just a clarification, as I didn't intend to hijack this thread - I simply suspect that this kind of documents is mostly non-existent at this time, and it's quite a lot of work to create them, and I believe that people should be rewarded for their efforts.

This is a service I offer on an individual-client basis. I offer to prepare any such documents myself, on a need basis, after looking into your individual needs and situation. These are not canned-type documents offered on a web store.

For some indication about my experience please visit my LinkedIn page, and browse my posts at Elsmar.

I will follow up with you re. pricing via a private message.

Cheers,
Ronen.
 
Last edited by a moderator:

MDRexpert

Involved In Discussions
#39
CEP, CDP and CIP

Can someone describe me the difference between the clinical development plan and Investigation plan. Do we have to have all plans in place.
I know the PMCF plan has to be a part of CEP but where does CDP and CIP fit?
It gets very confusing especially with the addition of PSUR. How is PMCF, PSUR and PMS report different?
Any help is appreciated. Thanks!
 
#40
Hi Steve
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
,

The SOP is very nice and i am writing some SOP for medical devices and please share any documents if you have or links.
 
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