Template: Literature Evaluation Table (MDR Clinical Evaluation)

Sebastian Skorka
Updated April 27, 2024

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This is a free template, provided by OpenRegulatory.

If you are a user of Formwork, our eQMS software, you can save a lot of time by choosing “QMS” on the top menu and “OpenRegulatory Templates” on the left menu, and then opening the relevant folder to find this template ready to load into Formwork.

If, for some mysterious reason, you’re using a different QMS Software, you can also simply download this template – specifically, as Word (.docx), PDF, Google Docs or Markdown file. Scroll down for a preview!

The template license applies (don’t remove the copyright at the bottom, don’t re-use this for commercial purposes).

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1. Introduction and Literature Evaluation

Copy this table into an Excel sheet to manage your literature. Modify this table to your needs and requirements.

Search categoryNo.ReferencePotentially relevant?Relevant after reading the full text?TitlePUI/PMIDAbstractCommentName of deviceClinical performance & benefitsUser experienceRisks
Clinical association1Add the publication reference here.Yes / NoYes / NoAdd the title of your publication here.Add the PubMed ID here.Copy paste the abstract here.Add your comments here.Name of your device, a similar device or the equivalent deviceList the clinical performance parameters.List usability related information.Lists risks mentioned in the publication.

Template Copyright openregulatory.com. See template license.

Please don’t remove this notice even if you’ve modified contents of this template.

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