Post Market Surveillance SOP and Procedure for Medical Device Manufacturers
A Post Market Surveillance SOP is the quality system procedure that defines how a manufacturer collects, analyses and reports post-market data for its medical devices. I3CGLOBAL supplies an editable PMS SOP with a PMS Plan template and record forms, prepared for EU MDR 2017/745 and ISO 13485:2016.
Overview
What Is a Post Market Surveillance SOP?
The PMS procedure applies to the whole company. It is the documented procedure behind the post-market surveillance system and the feedback process required by ISO 13485:2016, clause 8.2.1. A PMS SOP typically defines:
- Responsibilities of quality assurance, regulatory affairs, the PRRC and other departments.
- How customer feedback and complaints are received and recorded.
- How PMS data is collected and analysed.
- How trends, serious incidents and field safety corrective actions are escalated.
- How findings lead to corrective and preventive action (CAPA).
- How results are reviewed and reported.
PMS SOP or PMS Plan? The SOP is the general procedure. The Post Market Surveillance Plan applies it to one device and sets the device-specific data sources, indicators and thresholds. The results are then summarised according to the PMS Reporting Requirements. For the periodic safety update report, see our PSUR Procedure and Template.
Package and price
What Is in the PMS Documentation Package?
Our clinical team and QMS experts jointly developed these post market surveillance procedures and record templates in line with the MDR and MDCG guidance. For USD 250 you receive the full set below as editable Microsoft Word files, ready to adapt to your company and devices.
The $250 special package contains the following items
- Post-Market Surveillance Procedure
$100 - Post-Market Surveillance Plan
$200 - Customer Feedback Form
$50 - User Feedback Form
$50 - Sales Data
$50 - Review of PMS Plan
$50 - Post Market Surveillance Report -Sales Data-
$200
Samples
What Do the PMS SOP and Record Templates Look Like?
The tables below list each document in the set, with a sample of the procedure and of each record template.
Post Market Surveillance SOP / Procedure
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Number of Downloads: 657 |
Post Market Surveillance (PMS) Forms / Templates
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Number of Downloads: 320 |
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Number of Downloads: 91 |
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Number of Downloads: 23 |
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Number of Downloads: 431 |
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Number of Downloads: 29 |
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Number of Downloads: 31 |
Work with I3CGLOBAL
Need the PMS Documents Written for You?
If you prefer a finished document to a template, our regulatory team prepares the device-specific PMS Plan and writes the PMS Report or PSUR from your data.
- Post Market Surveillance Plan written to Annex III.
- PMS Report for Class I devices.
- PSUR for Class IIa, IIb and III devices.
Talk to our team
Send us your device list and risk classes. We reply with a scope, timeline and fee.
FAQs
What Should You Know Before Buying?
What is the refund policy?
We will NOT issue a refund once the softcopy document has been submitted.
Do the templates follow EU MDR 2017/745 requirements?
Yes. The Post Market Surveillance SOP, Plan and Report templates are prepared in line with EU MDR 2017/745 and EN ISO 13485:2016, clause 8.2.1.
What are the advantages of purchasing the procedures and templates?
CE Marking for medical devices, MDR Technical File, the clinical evaluation report should be concluded with the help of Post Market Surveillance (PMS) Procedure, Plan and Report with its final safety conclusion.
The report templates navigate proper direction to complete report faster with more accuracy.
Who is this Post Market Surveillance SOP template for?
These SOP templates are not designed for the general public. This template is drafted for professionals such as PRRC, MR, QA, RA, subject experts and technical writers engaged in MDR / UKCA technical documentation inhouse without the need for consulting support.
What is the file type, and are there any limitations on use?
All documents are made in Microsoft word. No limitation on use.
How can I receive the sales invoice?
The purchased softcopy document will be accompanied by an attached copy of the invoice. The invoice will be from PayPal, and there will be no separate or alternative invoice provided.
How can I obtain the purchased files and documents?
The files you purchase are instantly available for download via a page popup after the purchase. All files can be easily downloaded. However, in case of any difficulty, please write to enquiry@i3cglobal.com, and we will get back to you within 12 hours (excluding Sundays, as they are holidays).