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

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Document Management Training Management Product Development Design Control Risk Management CAPA Management Audit Management Supplier 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 Patient Reported Outcomes (ePRO) Ad-Hoc Data Collection (Cases) Post-Market Surveys Product Add-Ons

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Ultimate Guide to Comparing Quality Management System Solutions

This eBook compares the best QMS software solutions to help medical device companies make an informed decision when investing in a quality management system.

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Aaron Joseph

Aaron Joseph, principal consultant with Sunstone Pilot, is a biomedical engineer based in Waltham, Mass. He helps clients efficiently tackle risk management and design controls for new product development based on his broad experience from surgical robotics to medical imaging to IOT and SaMD products.

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Dynamic risk management for software-enabled medical devices
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Unpacking Common FDA Compliance Gaps: Pre-Market vs. Post-Market Realities

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