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PSUR Procedure

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PSUR Template, Procedure and SOP

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

Is the templates follow EU 2017/745 requirements?

Yes, the documents adhere to MDCG, MDR requirements.

What are the advantages of purchasing the procedures and templates?

The procedure and templates can save a lot of time and effort in compiling a report.

Who is this template for?

These 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? Are there any limitations on use?

All documents are made in Microsoft word. No limitation on use.

How can I receive the sales invoice /bill? Can I get Refund if not happy?.

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.

We do not refund the amount once the e-copy documents submitted.

How can I obtain the purchased files and documents?

The files you purchased are NOT instantly downloaded.

However, within 1-5 hours of receiving the payment confirmation (excluding Sundays as they are holidays), you will receive an email. Please ensure to check the email address provided during the purchase process.

The email will contain a DROPBOX link through which you can access and download the purchased files or documents.

(Read above terms and conditions before purchase)
PMCF Plan Template

Periodic Safety Update Report Procedure / SOP

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Number of Downloads (untill 10/2022) : 420

Item: Periodic Safety Update Report Procedure [I3C-PSUR-01]

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Item: PSUR Register [I3C-TEM-41]

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Item: PSUR Action Plan and Follow Up [I3C-TEM-42]

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