This Blog speaks about harmonization of FDA QSR and ISO 13485. Those who are new to the industry probably have so many questions like How do we start? Which Regulations need to follow? what is QSMR?
To begin with, we will first understand QMS. Quality Management system covers designing, manufacturing, structuring, risk management, product labeling, clinical data, storage and more. ISO 13485 Certification for Medical devices is a quality management system required for regulatory purposes.
QMSR-(Quality Management system regulation Explained)
QMSR Explained: What FDA QSR and ISO 13485 Harmonization means for Medical Device Companies
After the Four years, the US Food and Drug Administration (FDA) signalled its intent to align its Quality System Regulation (QSR) with the international standard ISO 13485:2016.
As per the FDA’s rule proposed on February 23,2022 for the new QMSR, The proposed QMSR will be the outcome of integrating the FDA’s Quality System Regulation (QSR) regulations for current Good Manufacturing Practices (cGMP) with ISO 13485:2016, the international consensus standard for medical device quality management systems. According to FDA’s analysis, the regulation as written would result in a cost savings of $439-533 million over 10 years for medical device establishments that comply with both standards.
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