Hiring or looking for a job in Digital Health? Check out our Digital Health Jobs board

Templates Clinical Evaluation Templates

March 5, 2024

Template: Literature Evaluation Table (MDR Clinical Evaluation)

Sebastian Skorka

Template Download

This is a free template, provided by OpenRegulatory.

If you are a user of Formwork, our eQMS software, choose "QMS" on the top menu and "OpenRegulatory Templates" on the left menu, and then open 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).

Download as Word File

docx

Download as PDF

pdf

Copy-paste to Google Docs

html

Download as Markdown

md
Tired of copy-pasting? If you want to save time and edit these templates directly, you can use Formwork, our eQMS software. And if you're looking for step-by-step instructions for filling them out, check out our Wizard :)

Don't Miss Updates to This Template

Subscribe to our newsletter and we'll keep you posted on which templates we've changed.

Questions? Still Lost in Regulation?

Good news! Our goal is to provide lots of stuff for free, but we also offer consulting if you need a more hands-on approach. We get stuff done really fast. Have a look!

Template preview

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 category No. Reference Potentially relevant? Relevant after reading the full text? Title PUI/PMID Abstract Comment Name of device Clinical performance & benefits User experience Risks
Clinical association 1 Add the publication reference here. Yes / No Yes / No Add 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 device List 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.

Template Copyright openregulatory.com. See template license.

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

Why Startups Fail Our Services Free Consulting Community
QMS Software List Notified Body Reviews UDI Video Course Conference 2021
About OpenRegulatory Join Us Digital Health Jobs
No Cookie For You Privacy Policy Imprint
No QMS on this planet will save you from creating crappy software.