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PSUR Template, Procedure and SOP

We have developed high quality Procedures and Templates /Forms for Periodic Safety Update Reports in compliance with MDR. During the preparation of Medical Device CE Marking Technical File, the Periodic Safety Update Reports with conclusion must be attached.

Important: Purchased files will be personally sent to the email address supplied upon payment.

You should expect a 2-5 hour wait in receiving the download link. Please notify if your email address changes.

PMCF Plan Template

Periodic Safety Update Report Procedure / SOP

Type : Procedure
Title : Periodic Safety Update Report Procedure
Document ID : I3C-PSUR-01/R1-11/19
Price : $200
Number of Downloads (until 10/2022) : 420

25 reviews

Periodic Safety Update Report (PSUR) Templates

Type : Templates
Title : Periodic Safety Update Report
Document ID : I3C-TEM-40/R1-11/19
Price : $350
Number of Downloads (until 12/2020) : 320

25 reviews

Type : Templates
Title : PSUR Register
Document ID : I3C-TEM-41/R1-11/19
Price : $50
Number of Downloads (until 12/2020) : 320

25 reviews

Type : Templates
Title : PSUR Action Plan and Follow Up
Document ID : I3C-TEM-42/R1-11/19
Price : $50
Number of Downloads (until 12/2020) : 320

25 reviews

Are you looking to buy? Please read and agree to the terms and conditions before proceeding with the purchase.


We have been in the regulatory consulting business since 1999. After two decades, we have grown to be one of the largest groups, with offices in more than six countries. More than 2000 companies are connected to us in some way and will always be with us in the coming years.

Our service quality is primarily determined by the highly qualified professionals who work with us. We value our customers and respond to them when they have a need.



The files you purchased are not downloaded automatically. After obtaining payment confirmation, you will receive an email within 1-6 hours. (Sundays are days off.)


Our technical experts create the softcopy procedures, templates, and checklists for sale after interpreting and debating guidelines. The briefings or explanations given in each section do not constitute an official or signed contract, and no grievances will be considered. Buyers should keep in mind that the writers are human beings, and there might be a few flaws as interpreted by regulatory authorities or other professional experts in this area.

Refund Policy

We will NOT issue a refund once the softcopy document has been submitted.



Softcopy procedures, forms, and checklists for sale must be updated and filled out according to the scope of the product. We cannot guarantee that simple forms will be accepted by the NB or FDA, but properly filled forms based on our advice will have a better chance of being accepted.


Along with the purchased softcopy document, a copy of the invoice will be attached. PayPal will produce the invoice. There will be no different invoice.

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