WEBINAR: Navigating FDA Regulation & Quality Management with Steve Gompertz, QRx Partners

​WEBINAR: Navigating FDA Regulation & Quality Management with Steve Gompertz, QRx Partners

​Presentation followed by Q&A 

• ​U.S. Medical Device Regulatory Basis

• ​Device Classification

• ​Regulatory Pathways

• ​Quality Management System Requirements

• ​Typical Startup Regulatory & Quality Evolution 

​Steve Gompertz (CQM, CBA, RAC-US, CMII) is a leader in Quality Systems management with over 25 years of experience in the life-science industry. His career includes roles in quality systems development and implementation, project management, engineering automation, configuration management, audit, and software development for companies including Pelican BioThermal, St. Jude Medical (now Abbott), Boston Scientific, Medtronic, Vital Images, and Control Data. He is now a consultant to the industry providing guidance on quality systems and regulatory compliance.

​Steve holds a B.S. in Mechanical Engineering from Lehigh University, and certifications in quality management, biomedical auditing, regulatory affairs, project management, and configuration management. Steve started his professional career in software development and then moved into systems implementation project management. After joining the medical device industry, he transitioned from implementing quality- related IT solutions to managing quality organizations and processes. Steve also helped St. Cloud State University develop and is a Sr. Adjunct Instructor in M.S. in its Medical Technology Quality program.