RegDesk Regulatory Roundup

Sep 6, 2019

Difference Between ISO 13485: 2012 and 2016

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...

Aug 28, 2019

North America

FDA Shifts from QSR and ISO 13485

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...

RegDesk Regulatory Roundup

Difference Between ISO 13485: 2012 and 2016

FDA Shifts from QSR and ISO 13485

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