The 9th Annual Medical Device Regulations Conference


November 15, 2022 - November 17, 2022    
All Day


GCMI’s Saylan Lukas and Chris Rolfes, PhD will be presenting on November 17th: “Total Product Life Cycle Management for Medical Devices Containing Software”



Design and development of a medical device with software has many facets, and it is best to know what is needed from the start. A typical first stage is planning, where user needs and technical requirements are laid out. This lays the foundation for design, verification & validation, regulatory submission and post market activities. This talk will provide a high level overview of design and development considerations, including risk analysis, failure mode analysis and software planning that will help guide product development and increase safety.


Christopher Rolfes earned his PhD from the University of Minnesota. He has worked in research in development in for more than 15 years, working at various settings including universities (Minnesota and Georgia Tech), Medtronic, and two small startups (including one of my own). He has spent the last six years at GCMI, a medical device testing and development CRO. During his career,  he has contributed toward testing and development of pacemakers, ablation systems, wearables, as well as surgical tools, thrombectomy systems, and more.