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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

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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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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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4 Helpful Tips for Better Management of Your Design History File

4-tips-for-managing-your-dhf

The design history file is a requirement for all Class 2 and above medical devices, along with some specified Class 1 devices. Here are some quick tips for managing your DHF. 

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