This training provides an overview of recent FDA 21 CFR 820 changes to Quality Management System Regulations (QMSR), especially related to the integration of ISO 13485:2016.
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4 hours
Combination lecture and classroom exercises
Available at QSG’s training facilities, on-site at your organization, and virtually
In February 2024, the FDA published the final rule for the Quality Management System Regulation (QMSR), integrating ISO 13485:2016 standards. This article details the QMSR’s implications, emphasizing the strategic adjustments medical device companies must make for compliance.
The QMSR applies to manufacturers, contract sterilizers, installers, relabelers, remanufacturers, repackers, specification developers, and initial distributors of foreign manufacturers. Additionally, component manufacturers are encouraged to voluntarily comply with the QMSR.
The harmonization between QSR and ISO 13485 addresses several challenges medical device manufacturers face. Historically, navigating the differences between regulatory regimes has been complex and resource-intensive. Misalignment between QSR and international standards often led to duplicative efforts, increased compliance costs, and delayed market entry. Manufacturers looking to enter the U.S. have been unable to fully leverage their ISO 13485 compliance, while U.S. manufacturers looking to enter the E.U. have needed double compliance to align their QSR-compliant quality systems to ISO 13485.
Harmonization offers a strategic solution to mitigate these challenges while fostering several key benefits:
Risk management is a requirement throughout ISO 13485:2016 and this course covers a summary for risk management in each of the elements.
This half (1/2) day training will inform you on recent FDA 21 CFR 820 changes to Quality Management System Regulations (QMSR), especially related to the integration of ISO 13485:2016.
Chris, Angelo and Barbara,
The recent meeting “What we can learn from FDA Warning Letter” was an excellent and exactly what I was looking for. Please keep me on the list for future meetings. Real professional of you folks. I have given your companies information out to an acquaintance from ASQ as a source for training for internal auditing. Looking forward to a long relationship with your team.
Hi Angelo,
Great ISO 13485:2016 Internal Auditing class, honestly the most well run and informative class I’ve taken.
Hi Angelo,
We are satisfied with the process and the report. Gordon does a good job! He is up on the regulations and what we need to focus on. I have found in past years what he points out is what comes up on the radar with the Notified Body. It helps us to be ready for the process.
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