The Use of Standards by a Medical Device Manufacturer

Register in advance for this meeting: 


Friday, May 8, 2020 -
2:00pm to 3:00pm
Zac Dooley

Manager of Research & Testing at SeaSpine in Carlsbad, CA

The Use of Standards by a Medical Device Manufacturer


This talk will cover how standards effect the daily interactions of a medical device manufacturer.  Additionally, it will provide an overview of how ASTM and ISO standards are formed and demonstrate how standards are involved in each and every step of a medical device coming to market from concept to final delivery to the customer.


Zac Dooley is the Manager of Research & Testing at SeaSpine in Carlsbad, CA.  He has been with SeaSpine since 2016.  He runs and manages all aspects of the mechanical test laboratory.  Mr. Dooley is also the voting member of SeaSpine to ASTM and serves as co-chair of ASTM’s subcommittee F04.25 on spinal devices.  He is also part of the USA delegation to ISO TC 150 (implants for surgery) and participates in ISO working groups on spinal devices and medical device coatings.

From 2005 to 2008, Mr. Dooley worked at the Shiley Center for Orthopaedic Research and Education (SCORE) at Scripps Green Hospital researching large joint implants and cartilage.  From 2008-2015, Mr. Dooley worked at NuVasive in the mechanical test laboratory performing standard mechanical tests on spinal hardware. While at NuVasive, he created a 6DOF spine simulator for use in cadaveric testing.

Mr. Dooley received his undergraduate degree from Marquette University in Milwaukee, Wisconsin in Bioelectronics Engineering with minors in Chemistry, Biology, and Electrical Engineering.  He also has a  master’s degree in Biomedical Engineering from the University of Southern California.