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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 Product Development Design Control Risk Management CAPA Management Audit 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 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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John F. Johnson III

John Johnson III practices FDA and Customs law at Benjamin L. England & Associates, LLC with a focus on integration of the two agencies’ regulatory compliance requirements, and has extensive experience with representing FDA-regulated clients before FDA, USDA, Customs and other regulatory agencies.

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Medical Device Compliance: Regulations, Standards, and Solutions
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The FDA Medical Device Approval Process: Pathways, Timelines, and Tips

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