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

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Featured Capabilities:

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

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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

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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.

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checklists and templates

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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