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

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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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FDA 483 / Warning Letter Response Template

fda 483-warning-letter-response-tempalte

Use this previously confidential FDA 483/ warning letter response template to provide information to FDA in a manner that is both easy to understand and navigate.

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