.png)
The FDA has finalized a major final rule to amend device current good manufacturing practice requirements of the Quality System Regulation (QSR) in 21 CFR Part 820. This is the first major revision of Part 820 since 1996. The agency issued its Quality Management System Regulation (QMSR) on January 31, 2024, and then published the final rule in the Federal Register on February 2, 2024. The rule is effective on February 2, 2026, giving manufacturers a two-year transition window to get their Quality Management Systems into compliance.
Comprehending the differences between the new FDA QMS Regulations and the old QSR is crucial for effective transition planning. Adding ISO 13485:2016 by reference is the biggest modification to the FDA QMSR. The FDA QMSR aligns U.S. rules with international norms, in contrast to QSR, which was based only on FDA-defined obligations. International manufacturers can now deploy uniform quality management systems in all markets because of the FDA's QMSR harmonization. Equally important, QMSR explicitly integrates ISO 14971 risk management principles through the addition of ISO 13485:2016, which marks a decisive shift toward a risk-based approach to quality system management.
To help illustrate exactly what has changed, we’ve put together the following side-by-side comparison table. It shows how QSR requirements map against QMSR updates, and highlights where risk management and ISO standards now take center stage.
AltaQ has extensive experience implementing Quality Systems under both QSR and ISO 13485. Our proven experience and regulatory expertise enable us to efficiently update existing quality systems and implement QMSR requirements, including the critical integration of ISO 14971 risk management requirements into design control processes. We understand the nuances of transitioning from traditional QSR-based systems to the harmonized QMSR framework, ensuring compliance while maintaining operational efficiency throughout the implementation process.
Our validation services encompass analytical validation, software verification, and facility qualification programs designed to demonstrate compliance with risk-based quality management requirements. Additionally, our EU IVDR expertise and CE marking capabilities enable manufacturers to leverage QMSR compliance for accelerated European market access, implementing unified quality systems that support both FDA and EU regulatory requirements while reducing long-term compliance costs through strategic harmonization.
There are only six months left before a changing inspection landscape. Now is the time to move from awareness to execution! Let’s talk: info@altaq.com
David Heffelfinger joined AltaQ in December 2017. Prior to AltaQ he was Site Manager & Senior Director of Engineering for QIAGEN. As VP Engineering at PrimeraDx (acquired by QIAGEN), David contributed to a highly successful 501K submission and clearance by the FDA. In addition, he was an engineering executive at Beckman Coulter, BD Biosciences, and Bio-Rad Laboratories as well as at several startups and venture capital-backed companies including Biometric Imaging, Alpha Innotech Corp, and Luminys Systems. Dave was also a founder of his own company, Hyperspectra LLC. He has a B.S./M.S. in Physics from Wayne State University and an M.B.A. from Saint Mary’s College (Moraga CA).
Close
Zain holds a Master’s degree in Bio and Immunoengineering from the Pritzker School of Molecular Engineering at the University of Chicago, and a Bachelor of Science degree in Bioengineering from Northeastern University in Boston. He has also earned the Designing and Building AI Products and Services certificate from the Massachusetts Institute of Technology. Zain has completed engineering co-ops with EyeCool Therapeutics and Suono Bio where he supported clinical and product development.
Close
Fayyaz Memon has over 30 years of regulatory, quality and clinical experience in the IVD/LDT, medical device, and biotech industries. Fayyaz held progressive roles at a number of companies, including Natera, Biological Dynamics, Asuragen, Qiagen, PrimeraDx, ThermoFisher, Innovative Neurotronics, Digene, Pfizer, and J&J.
He has built a unique professional portfolio combining his QA/RA expertise with clinical, manufacturing, software, operations, and project management experience. He has a successful track record in guiding multiple companies to achieve regulatory approvals and successful commercialization.
Fayyaz has completed regulatory projects in the USA, Europe, and Asia. Fayyaz received his M.S. in Engineering and his M.B.A. from Drexel University.
Close
David Liu has over 12 years of quality and regulatory experience in the IVD/LDT and medical device industries. Prior to AltaQ, David established the quality department at Biological Dynamics and successfully obtained ISO 13485 certification. David contributed towards technical files for successful regulatory submission as well as FDA breakthrough device designation. He has a B.S in Chemistry from UNC-Chapel Hill and a PhD in Chemistry from University of Florida.
Close
.jpg)
Fayyaz Memon has over 30 years of regulatory, quality and clinical experience in the IVD/LDT, medical device, and biotech industries. Fayyaz held progressive roles at a number of companies, including Natera, Biological Dynamics, Asuragen, Qiagen, PrimeraDx, ThermoFisher, Innovative Neurotronics, Digene, Pfizer, and J&J.
He has built a unique professional portfolio combining his QA/RA expertise with clinical, manufacturing, software, operations, and project management experience. He has a successful track record in guiding multiple companies to achieve regulatory approvals and successful commercialization.
Fayyaz has completed regulatory projects in the USA, Europe, and Asia. Fayyaz received his M.S. in Engineering and his M.B.A. from Drexel University.
Close
