Careers Support Contact Sales
Products

More than a Quality Management System: Tools for the entire MedTech Lifecycle.

Learn More

Featured Capabilities:

Document Management Product Development Design Control Risk Solutions Training Management CAPA Management

Experience the #1 QMS software for medical device companies first-hand. Click through an interactive demo.

View Product Tour

Data collection and management designed for MedTech clinical trials.

Learn More

Featured Capabilities:

Electronic Data Capture (EDC) Electronic Case Report Forms (eCRF) Electronic Patient Reported Outcomes (ePRO) Ad-Hoc Data Collection (Cases) Post-Market Surveys

Get a personalized demo of Greenlight Guru Clinical today.

See the Demo

Learn valuable, career-boosting skills for the Medical Device industry. Get access to hundreds of free resources as well as subscription-based courses and certifications.

Learn More
Solutions
Why Us
Customers
Partners
Company
Resources
ROI Report Cover

Calculate Your ROI
See the Demo
See the Demo
See the Demo
checklists and templates

Checklist: Premarket Submission Documentation for Devices Containing Software

Clinical Investigation Report Checklist copy

A free checklist of the seven must-have documents to include in a premarket submission for SaMD and devices that contain software that you will be sending to CDRH for final review.

Want more free medical device resources? Click here to access our full library of downloadable content!

 

© 2023 Greenlight Guru. All rights reserved. Legal Info

Yes, I want the resource!
© 2023 Greenlight Guru. All rights reserved. Legal Info