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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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Featured Capabilities:

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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Abbreviated 510(k) Submission Checklist

Abbreviated 510(k) Submission Checklist

Want to make sure you’ve included all of the necessary sections in your Abbreviated 510(k) submission to FDA? This free downloadable checklist can help.

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

 

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