FDA's Quality Management System Regulation Revised (QMSR) for Medical Devices
Simple Guide to FDA’s harmonization of 21 CFR part 820 with ISO 13485:2016
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5 Ways to Stay Compliant with 21 CFR Part 11
Learn how to stay compliant with FDA's Part 11 in the age of automation!
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What are CAPAs?
Learn the purpose of Corrective and Preventive Actions (CAPAs) for Medical Device Development.
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How to Create Successful SOPs for your Medical Device
Explore the key considerations for Standard Operating Procedures (SOPs) for Medical Device Companies
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What are Standard Operating Procedures (SOPs)?
Defining SOP’s as they pertain to your Medical Device.
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5 Best Practices for Pharmaceutical Labeling
How strategic labeling can improve regulatory compliance and operational efficiency
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FDA’s Emergency Use Authorization (EUA) to Combat the Coronavirus
How Emergency Use Authorization is shaping the regulatory landscape of Healthcare during the COVID-19 pandemic.
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How to Utilize CAPA in 10 Easy Steps
Step by step instructions on navigating your Corrective Action & Preventive Action (CAPA) for FDA.
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