Post Market Surveillance SOP - Word Version

D

drkgladd

#11
Steve, I work for a medical device company as a Regulatory Manager. I've been struggling with documenting a thorough PMS procedure. Your help is greatly appreciated.
Kind Regards,
drkgladd
 
Elsmar Forum Sponsor
J

jslens

#12
Hi bensnow,

Welcome to the Cove :bigwave:

In most organizations, yes, its the Quality Manager responsible for PMS.
Hi
I'm contact lens manufacturer in Korea. Few days ago, I had annual audit.
They said some part was changed, That' s Why i prepare PMS reports.
But it is not easy preparing PMS. Does anyone can show me full version of PMS?
Thanks

 
C

chetanupadhyay

#14
Hi,

Same procedure i used but then also i got NC

"Post market surveillance process can be made more clear. It is referring to many processes and is not clear when and how products from the market will be taken and what will be analysed/tested, what are the open channels of communication for the customer to make complaints"

So, If you have any revise SOP then let me know.
 
S

SteveK

#15
No significant changes to SOP, just an indication that you can also use competitor literature/website as a source of information and updated the references.

Steve
 

Wolf.K

Quite Involved in Discussions
#16
Hi,

I wonder how you are going to update your SOP for 13485:2016 compliance? Currently I am looking for information how to incorporate the new/extended requirements for the risk management. The SOPs from the Medical Device Academy got a new chapter "Risk management", and they list some possible hazards and what risk control measures have to be performed to eliminate the hazards. Do you think this is enough to fulfill the requirements? Or do you have other ideas? In the end, all our PMS results are input to the risk evaluation.

Greetings
Wolf
 
S

SteveK

#17
As indicated in another post I have added this clause reference and statement to the scope of all my procedures as an update to ISO 13485:2016, including my PMS SOP.

4.1.2b A risk based approach will be applied to the control of the appropriate processes within this Procedure.

As to overall Risk Management, I just follow ISO 14971 (no separate SOP) to create a Risk Management section for each of my Technical Files. This gets updated if I find any additional hazards (and potential solutions) for a particular device similar/equivalent to one of ours e.g. reported by regulatory authorities such the MHRA, FDA, TGA etc. Not sure if this answers your question.

Steve
 
K

khurshid

#19
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
hi.
we have the same issue .
auditors ask about pms plans and pms report. sops
if any one have plz share
 
J

Jeffers

#20
Hello Steve,
I been around the site trying to locate information about, "Clinical Evaluation Reports" and how they should be updated to address the updates to Meddev 2.7.1 Rev 4.
I saw the attachments that you have included on some other posts, but they were all created before revision 4 in 2016.
Just to confirm, did you add this clause to address the changes in revision 4? "4.1.2b A risk based approach will be applied to the control of the appropriate processes within this Procedure".
Does anyone have a CER that has been reviewed by a NB after the publishing of Meddev 2.7.1 rev 4? Here is what I have located on Elsmar in reference to this:
Clinical Evaluation for Class I Medical Devices
Medical Device Clinical Evaluation Standard Operating Procedure / SOP
Post Market Surveillance SOP - Word Version

Is there another post I am missing? Thank you to Elsmar in advance for all of your wonderful resources.
 
Thread starter Similar threads Forum Replies Date
N Post Market Surveillance Package Example Wanted ISO 13485:2016 - Medical Device Quality Management Systems 1
M Post Market Surveillance for Class II Medical Devices Medical Device and FDA Regulations and Standards News 2
H Post-market surveillance strategy EU Medical Device Regulations 2
B Procedures for Complaint Handling and Post Market Surveillance EU Medical Device Regulations 7
M Informational Creating a post market surveillance (PMS) system for medical devices – Part 1 Medical Device and FDA Regulations and Standards News 7
E Post Market Surveillance Standard Various Other Specifications, Standards, and related Requirements 4
T Post-Market Surveillance Plan - Requirements outlined in Annex III (1.1b) EU Medical Device Regulations 2
Y Post Market Surveillance Indicators and Analysis method EU Medical Device Regulations 1
M Post Market Surveillance Plan Template EU Medical Device Regulations 10
F Vietnamese Post-Market Surveillance Requirements for a medical device in Japan Other Medical Device Regulations World-Wide 0
S Post Market Surveillance and Annual Product Review in ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 2
M Medical Device News Health Canada Notice of intent: Strengthening the post-market surveillance and risk management Canada Medical Device Regulations 1
K EU MDR - PMS (Post Market Surveillance) SOP - definition of "register(s)" EU Medical Device Regulations 2
S An auditor asked for a Post Market Surveillance Report ISO 14971 - Medical Device Risk Management 4
T Proactive / Preventive Post Market Surveillance question ISO 13485:2016 - Medical Device Quality Management Systems 4
M ISO TR 20416 Medical Devices - Post-Market Surveillance for Manufacturers Other Medical Device Related Standards 6
S Merging Post Market Surveillance and Complaint Handling ISO 13485:2016 - Medical Device Quality Management Systems 3
S Post Market Surveillance procedure/ SOP Medical devices Imported Legacy Blogs 0
A Industry best practice about Post-Market Surveillance and Risk Analysis ISO 14971 - Medical Device Risk Management 6
S Korean Post Market Surveillance and Recall Regulations Other Medical Device Regulations World-Wide 3
D What is your Post-Market Surveillance Strategy 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
S Understanding PMS (Post Market Surveillance) and PMCF (Vigilance and PMCF) Quality Manager and Management Related Issues 1
Z When to stop Post Market Surveillance 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
C How to write a Post Market Surveillance REPORT (not procedure) EU Medical Device Regulations 4
N MEDDEV guideline on Post Market Surveillance (PMS) EU Medical Device Regulations 8
Q Post Market Surveillance SOP - ISO 13485 Audit Nonconformance ISO 13485:2016 - Medical Device Quality Management Systems 3
T Post Market Surveillance Sample Procedure for Medical Devices EU Medical Device Regulations 2
A Applicable Regulations for a PMS (Post Market Surveillance) System ISO 14971 - Medical Device Risk Management 5
J ISO 13485 - Procedure for a Feedback System (Post Market Surveillance) ISO 13485:2016 - Medical Device Quality Management Systems 10
T Post Market Surveillance Requirements in Israel Other Medical Device Regulations World-Wide 17
L Lost in the Post-Market Surveillance Clinical Follow-up EU Medical Device Regulations 1
E Post Market Surveillance Guidelines or examples of procedures US Food and Drug Administration (FDA) 9
K Post-Market Clinical Follow-up as part of Post Market Surveillance? EU Medical Device Regulations 15
D 'Post market surveillance' versus 'Post Market Clinical Follow Up' EU Medical Device Regulations 18
J Post-Market Surveillance required by the EU's MDD vs. ISO 13485 Requirements ISO 13485:2016 - Medical Device Quality Management Systems 55
B ISO13485 Sterilisation Validation, Risk Management, Post Market Surveillance ISO 13485:2016 - Medical Device Quality Management Systems 13
thisby_ Post Market/Production Risk Assessment ISO 14971 - Medical Device Risk Management 0
M Differences in post market safety reporting for Combination Product Applicants Medical Device and FDA Regulations and Standards News 1
K Product (Device) Life cycle - Product Life AFTER the Post Market Phase Medical Device and FDA Regulations and Standards News 3
A Post-market clinical followup studies (PMCF) EU Medical Device Regulations 16
M PMCF (Post Market Clinical Followup)/ PSUR template EU Medical Device Regulations 8
S PMCF (Post Market Clinical Followup): Rationale for Exemption - Software Medical Devices EU Medical Device Regulations 6
K Post Market Clinical Follow up and CE Marking for Class IIb medical X-Ray products CE Marking (Conformité Européene) / CB Scheme 1
W Interesting Discussion PMCF (Post-Market Clinical Followup) vs PMCF studies EU Medical Device Regulations 36
C PMCF (Post Market Clinical Followup) Enrollment Sizes (Spinal Implants) EU Medical Device Regulations 5
A Post-market Clinical Studies of Orthopaedic (Revision) Implants EU Medical Device Regulations 1
S Verification and Validation of Post Market Design Change Design and Development of Products and Processes 2
S Post Market Clinical Follow up (PCMF) Clarification EU Medical Device Regulations 6
D Post-Market Compliance with Investigational AEs 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
L Surveys for post-market clinical follow-up EU Medical Device Regulations 1

Similar threads

Top Bottom