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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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FDA QSR, QMSR & ISO 13485:2016 Internal Audit Checklist

FDA QSR, QMSR & ISO 13485_2016 Internal Audit Checklist - slide-in cover

Use this free, customizable tool to compare your MedTech company’s QMS practices and procedures to the requirements of FDA QSR, QMSR and ISO 13485:2016.

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