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FDA Guidance on Adverse Event Reporting to IRBs - Improving Human Subject Protection

By: www.fda.gov
Date: December 02, 2011

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Compliance Trainings

Pregnancy in the Workplace: Strategies to Protect Your Organization from Pregnancy Discrimination Claims
By - Christopher W. Olmsted
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How to Vet an IRB: Expose and Fix Problems Before They Threaten Your Trial
By - Madhavi Diwanji
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DMR & DHR - What Is Really Required
By - Daniel O Leary
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Compliance Standards

Checklist for applying IEC 62304:2015 ''Medical Device Software - Software Life Cycle Processes''
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A Software Engineering Kit – Composed of Templates for Key Software Engineering Process Plans
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ISO/IEC 20000-1:2011 “Information Technology – Service Management –Part 1: Service Management System Requirements”
Price: $330Add to Cart

Software Quality Kit
Price: $748Add to Cart

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General requirements for the competence of testing and calibration laboratories
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IEC 62304:2015 ''Medical Device Software - Software Life Cycle Processes''
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IEC 62304:2015 ''Medical Device Software - Software Life Cycle Processes''
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ISO 45001:2018 Gap Analysis Checklist
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Zero Acceptance Number Sampling Plan for Receiving, In-Process and Final Inspection
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