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PMCF PLAN TEMPLATES

PMCF Plan Template and Example

PMCF Plan as per MDR article 83 is hard to understand, so preparation of fully complying with PMCF Plan template is hard for newcomers as well as those who have less time to spend on research.

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Is the PMCF Plan template follow EU 2017/745 requirements?

Yes, the documents adhere to MDCG, MDR 4 requirements.

What are the advantages of purchasing the documents?

The templates and procedures help in understanding the process faster. It also helps create the reports more efficiently.

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 included?

As per MEDDEV 2.12-2 rev 2, and MDR Annex XIV Part B paragraph 6.2, each device PMCF study should have a well-defined PMCF plan describing the design and methodologies for proactive clinical data collection to ensure that safety, performance, user feedback, and clinical experiences. It’s really hard for getting all the elements of the PMCF in the right way, so use our ready and customizable PMCF Plan template and Procedure. Our experts spend time and effort to develop procedures and templates suitable for buyers to edit and use.

What is the file type? Are there any limitations on use?

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

Refund Policy

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

How can I receive the sales invoice /bill??

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 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 detailed terms and conditions before purchase)

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PMCF Plan Template

PMCF Plan Procedure / SOP

47 reviews

Number of Downloads (untill 10/2022) : 220

Item: PMCF Procedure [I3C-PMCF-01]
Number of pages : 10

Price : $200

PMCF Plan Template / Forms

	02 reviews Number of Downloads (untill 10/2022) : 14 Item: Indications of PMCF Study [I3C-TEM-22] Number of pages : 10 Price : $50
	147 reviews Number of Downloads (untill 10/2022) : 743 Item: PMCF Plan [I3C-TEM-23] Number of pages : 10 Price : $300
	04 reviews Number of Downloads (untill 10/2022) : 14 Item: PMCF List of Study Centers [I3C-TEM-24] Number of pages : 10 Price : $50
	03 reviews Number of Downloads (untill 10/2022) : 09 Item: Extended Follow Up of Clinical Investigation [I3C-TEM-25] Number of pages : 10 Price : $1000
	02 reviews Number of Downloads (untill 10/2022) : 47 Item: New Clinical Investigation [I3C-TEM-26] Number of pages : 10 Price : $850
	02 reviews Number of Downloads (untill 10/2022) : 11 Item: Device Registry Data [I3C-TEM-27] Number of pages : 10 Price : $850
	84 reviews Number of Downloads (untill 10/2022) : 525 Item: Retrospective Study [I3C-TEM-28] Number of pages : 10 Price : $350
	67 reviews Number of Downloads (untill 10/2022) : 211 Item: Analysis & Conclusion [I3C-TEM-29] Number of pages : 10 Price : $350
	118 reviews Number of Downloads (untill 10/2022) : 712 Item: PMCF Evaluation Report [I3C-TEM-30] Number of pages : 10 Price : $350