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Archives
Inspections and Audits
Webinar
EU-MDR: Are You Ready? An Exclusive Three-Part FDAnews Webinar Series
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Webinar
Apr. 07, 2020
FDA CDS Software Regulation: The Latest Guidance on Clinical Decision Support Software
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Webinar
Apr. 10, 2020
EU-MDR: Are You Ready? Part II: Tips for Assessing Your Readiness Prior to Notified Body Review
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Webinar
Apr. 16, 2020
Medical Device Change Management
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Webinar
May 07, 2020
Calculating an ROI of Quality: How QMS Upgrades Can Drive Revenue
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Conference
Oct. 07, 2020
–
Oct. 09, 2020
15th Annual FDA Inspections Summit
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Upcoming Events
31
Mar
Informed Consent: Human Subject Protection in the Digital Health Age
01
Apr
Part 3: Clinical Trials in the Era of COVID-19 – The Changes You Need to Make Now
10
Apr
EU-MDR: Are You Ready? Part II: Tips for Assessing Your Readiness Prior to Notified Body Review
Featured Products
Biological Risk Evaluation and Management for Medical Devices
GMP Inspection Preparation Checklist: A Tool for Internal Auditing
Featured Stories
Thermo Fisher Gets CE Mark for Coronavirus Test
Sanofi and Translate Bio Collaborate Over COVID-19 Vaccine Candidate
J&J Predicts Phase 1 Trials of COVID-19 Vaccine by September
Abbott’s 15-Minute COVID-19 Test Authorized for Emergency Use
The Revised ICH E8:
A Guide to New Clinical Trial Requirements
Learn More
