OpenRegulatory Template

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.

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