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

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Featured Capabilities:

Document Management Training Management CAPA Management Audit Management Product Development

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

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Accelerate development with integrated design control and risk software.

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Design Controls Risk Management Risk Intelligence

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Data collection and management designed for MedTech clinical trials.

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Featured Capabilities:

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

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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!

 

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