Whitepaper
The Impact of the Updated FDA Quality Management System Regulation (QMSR)
February 02, 2024 Mark Rimbergas
It has been over 25 years since the FDA last made significant revisions to quality system regulations in the US. However, as of February of 2022, the FDA has amended the current Good Manufacturing Practice (cGMP) requirements of the quality system regulations to incorporate medical devices, quality management systems and requirements for regulatory purposes. Read this whitepaper to learn…
- The details and timeline of the amendments and what requirements are included.
- The similarities and differences between the current quality system regulations and the updated quality management system regulations.
- It’s impact on laboratory developed tests.
Mark Rimbergas
Mark has assurance and compliance expertise and also performs gap
assessments and provides guidance to help clients succeed.
Mark has nearly 30 years of experience in the medical device, pharmaceutical, and biotechnology industries, working with companies that range from start-ups in pre-clinical phases to fully established entities. Leveraging his experience in GCP, GLP, GCLP, GMP, and GDP, he has helped organizations implement effective quality systems. He has also helped organizations address warning letters, consent decrees, and other regulatory actions.
His key medical device domains include IVDs, Class II, and III implantable grafts and stents, combination products including injectable drug devices, medical imaging devices and software, hematology, and urinalysis devices.
Mark received his Bachelor of Science in Biology from Benedictine University, his Master of Science in Medical Informatics from Northwestern University, is a Lean Six Sigma Green Belt, is an ASQ Certified Quality Auditor (CQA), is an ASQ Certified Medical Device Auditor (CMDA), and most recently, a graduate of the Executive Leadership Program at Oxford University – Saïd Business School.
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Mark has nearly 30 years of experience in the medical device, pharmaceutical, and biotechnology industries, working with companies that range from start-ups in pre-clinical phases to fully established entities. Leveraging his experience in GCP, GLP, GCLP, GMP, and GDP, he has helped organizations implement effective quality systems. He has also helped organizations address warning letters, consent decrees, and other regulatory actions.
His key medical device domains include IVDs, Class II, and III implantable grafts and stents, combination products including injectable drug devices, medical imaging devices and software, hematology, and urinalysis devices.
Mark received his Bachelor of Science in Biology from Benedictine University, his Master of Science in Medical Informatics from Northwestern University, is a Lean Six Sigma Green Belt, is an ASQ Certified Quality Auditor (CQA), is an ASQ Certified Medical Device Auditor (CMDA), and most recently, a graduate of the Executive Leadership Program at Oxford University – Saïd Business School.
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