Dr. Levin has many years of experience working with the clinical laboratory and FDA Quality Management Systems. In his role as Postmarket Team Lead in the Division of Molecular Genetics and Pathology, Office of In Vitro Diagnostics and Radiological Health, CDRH/FDA, Dr. Levin was responsible for overseeing the review of Quality Management System submissions from companies seeking FDA clearance or approval.  In this role Dr. Levin worked with a number of clinical laboratories including Myriad Genetics, ARUP and Foundation Medicine in the conversion of their CLIA-based Quality System to one that was FDA compliant.  He and his colleagues published the attached article describing their experiences.  In collaboration with a national consulting group, Dr. Levin and his FDA colleagues visited several large clinical laboratories to discuss differences between the CLIA and FDA quality systems. 

 

In his role as Associate Director at PGDx, Dr. Levin was primarily responsible for converting the company's CLIA-based QMS into one that was compliant with FDA and ISO 13485:2016.  Dr. Levin achieved ISO 13485:2016 certification for PGDx in 2018. See the attached presentation (which is publicly available) from Dr. Levin's time at PGDx.

 

In his current role as a regulatory/quality consultant, Dr. Levin works with several clinical labs in upgrading their system to be compliant with FDA. Dr. Levin has numerous contacts in the clinical laboratory community who would be able to support this project as needed. Dr. Levin earned a BS from Brandeis University and a PhD from Harvard University.