Amanda Depalma Email Address

Vice President of Regulatory Affairs

Endologix is a developer and manufacturer of minimally invasive treatments for aortic disorders.

Bob DePalma bob.depalma@pyrexar.com 844-797-3927 Bob DePalma is a highly respected expert in the exceptionally complex and diverse world of medical device regulatory requirements. He has successfully handled 53 510(k) filings, 4 PMAs and 18 cGMP and 9 ISO13485 audits over the past 30 years, typically receiving all clearances with expedited results, while maintaining highly positive relationships with FDA, ISO and GMP auditors. His executive management experience also includes responsibility for quality assurance, continuous improvement, and metrology/UL testing as well as training management, production staff and service engineers in good manufacturing practice and ISO compliance. Bob is a member of American Society of Quality, Regulatory Affairs Professional Society and National Electrical Manufacturers Association.