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PMCF Plan Template & Procedure
Post Market Clinical Follow Up (PMCF) as per MDR article 83 is hard to understand, so preparation of fully complying PMCF procedures and templates is hard for newcomers as well those who has less time to spend in research.
As per MEDDEV 2.12-2 rev 2,and MDR Annex XIV Part B paragraph 6.2, each device PMCF study should have well defined plan describing the design and methodologies for proactive clinical data collection to ensure that safety, performance, user feedback, and clinical experiences. Its really hard for getting all the elements of the PMCF in right way, so use our ready and customizable procedure and templates.
Our experts spend time and effort to develop procedures and PMCF plan template suitable for buyers to edit and use. Interested parties can write to us or purchase directly from the I3CGlobal website.
Attention!!!
Purchased files will be sent via the DROPBOX link in 1-2 hours. DROPBOX link will be active for six months and any revisions if so, it will auto-updated.
In case of any delay or unable to download files, please write to enquiry@i3cglobal.com with the fund transaction ID.
Post Market Clinical Follow Up (PMCF) Plan Procedure / SOP
PMCF Procedure : 200 USD Procedure ID : I3C-PMCF-01/R2-10/19 |
Post Market Clinical Follow Up (PMCF) Forms / Templates
PMCF Device Selection : 50 USD Template ID : I3C-TEM-22/R2-10/19 | |
PMCF Plan : 300 USD Template ID : I3C-TEM-23/R2-10/19 | |
PMCF List of Study Centers : 50 USD Template ID : I3C-TEM-24/R1-08/19 | |
PMCF - Extended Follow Up of Clinical Investigation : 1000 USD Template ID : I3C-TEM-25/R1-08/19 | |
PMCF - New Clinical Investigation : 850 USD Template ID : I3C-TEM-26/R1-08/19 | |
PMCF - Device Registry Data : 850 USD Template ID : I3C-TEM-27/R1-08/19 | |
PMCF - Retrospective Study : 350 USD Template ID : I3C-TEM-28/R2-10/19 | |
Analysis & Conclusion : 350 USD Template ID : I3C-TEM-29/R2-10/19 | |
PMCF Evaluation Report : 350 USD Template ID : I3C-TEM-30/R2-10/19 |