Apr 19, 2022
FDA
The article provides an overview of the regulatory framework related to the quality system information and highlights the most important aspects associated thereto. Table of Contents The Food and Drug Administration (FDA or the...
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Sep 6, 2019
Uncategorized
What Is It? ISO 13485 is a quality management system that is used internationally. It controls safety in work environments, risk management, and design, and creates requirements for inspections, documents, procedures, and verification of safety and effectiveness of...
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Aug 28, 2019
North America
The FDA will shift from QSR to ISO 13485 so that their system regulations can harmonize with international practices to reduce confusion and and lessen the burden for medical device manufacturers. What is QSR Quality System Regulation (QSR), also known...
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