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PMCF Plan Template & Procedure

 PMCF (Post Market Clinical Follow-Upp) as per MDR article 83 is hard to understand, so preparation of fully complying with PMCF procedures and templates is hard for newcomers as well as those who have less time to spend on research.

 

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 Procedure and templates. Our experts spend time and effort to develop procedures and templates suitable for buyers to edit and use.

 

Interested parties can write to us or purchase directly from the I3CGLOBALwebsite.

PMCF Plan Template

Post Market Clinical Follow Up (PMCF) Plan Procedure / SOP

Type : Procedure
Title : PMCF Procedure
Number of pages : 10
Price : $200
Number of Downloads (until 10/2022) : 220

rating
47 reviews

Post Market Clinical Follow Up (PMCF) Forms / Templates

Type : Template
Title : Indications of PMCF Study
Number of pages : 10
Price : $50
Number of Downloads (until 10/2022) : 14


02 reviews

Type : Template
Title : PMCF Plan
Number of pages : 10
Price : $300
Number of Downloads (until 10/2022) : 743


147 reviews

Type : Template
Title : PMCF List of Study Centers
Number of pages : 10
Price : $50
Number of Downloads (until 10/2022) : 14


04 reviews

Type : Template
Title : Extended Follow Up of Clinical Investigation
Number of pages : 10
Price : $1000
Number of Downloads (until 10/2022) : 09


03 reviews

Type : Template
Title : New Clinical Investigation
Number of pages : 10
Price : $850
Number of Downloads (until 10/2022) : 47


02 reviews

Type : Template
Title : Device Registry Data
Number of pages : 10
Price : $850
Number of Downloads (until 10/2022) : 11

rating
02 reviews

Type : Template
Title : Retrospective Study
Number of pages : 10
Price : $350
Number of Downloads (until 10/2022) : 525

rating
84 reviews

Type : Template
Title : Analysis & Conclusion
Number of pages : 10
Price : $350
Number of Downloads (until 10/2022) : 211


67 reviews

Type : Templates
Title : PMCF Evaluation Report
Number of pages : 10
Price : $350
Number of Downloads (until 10/2022) : 712


118 reviews

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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.

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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.

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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.

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