Creating an Automated Test Strategy and Framework for Regulated Medical Device Software

Dr. Bradley Carlson

Dr. Bradley Carlson is an accomplished research and development executive and researcher with more than 30 years of academic and industrial experience in the medical device and imaging fields. He was most recently VP of R&D for LivaNova Neuromodulation where he led the development of the first VNS (vagus nerve stimulation) connected platform and associated digital infrastructure. Prior to LivaNova he led the development of x-ray imaging products for Envista Holdings and Danaher, and imaging-based scanners for Motorola. He was on the faculty of the ECE department at the University at Stony Brook where was Associate Professor. He has a PhD in computer engineering from Syracuse University. He is inventor on 52 issued US patents and author on 41 refereed articles.

Samanwaya Das, Senior Consultant, Quality Assurance, GlobalLogic

Samanwaya Das is a highly experienced professional with over 14 years of work in the Healthcare (Med-tech) industry. He is certified as a Scrum Product Owner and Scrum Master and holds a Bachelor’s in Electronics and Telecomm Engineering. He has over 5 years of experience as a Technical Project Manager and Scrum Master. He has exceptional expertise in Manual and Automated Verification and Validation, with more than 12 years of experience. His extensive knowledge of ISO 13485, ISO 14971, IEC 62304, and Regulatory Affairs with FDA and TUV-SUD standards makes him stand out in the industry.

Vincent Eppner, Vice President, Head of System DevOps and Quality Assurance, Siemens Healthineers

Vincent Eppner has over 20 years of experience in medical device development at industry giants Fujifilm Medical, GE Healthcare, and presently Siemens Healthineers.  He brings a wealth of expertise and has successfully led transformative shifts from Waterfall to Agile methodologies and spearheaded DevOps and Industrial DevOps implementations. Vincent’s extensive knowledge includes defining and leading quality strategies across Functional, Integration, Security, Regression, Usability, System, EMC, and Safety testing. Notably, he has experience in implementing automation test frameworks for Cloud, software-only, and cyber-physical products, demonstrating a comprehensive understanding of cutting-edge testing practices.

Richard Lett, VP of Healthcare Technology, GlobalLogic

Richard is a graduate of Purdue University and has over 23 years of experience developing medical devices, drug delivery systems, and Med-tech products for companies like Bayer, Baxter, and Amgen. Before joining GlobalLogic, Richard worked as a consultant for other large Medical Device and Med-tech companies. His expertise includes software & systems engineering and program management across the product development life-cycle from concept to commercialization, including FDA and EU regulations for medical devices and combination products.

Diana Miller, Senior Director, Medtronic Diabetes Software R&D

Diana Miller, Senior Director, Bakken Fellow, and Technical Fellow, is part of the Software R&D organization at Medtronic Diabetes, and she is responsible for developing and deploying medical mobile apps. She is also a Diabetes AI Portfolio leader with over 13 years of experience, successfully deploying new technologies and methods to deliver quality products to patients and solve business needs. She was also involved in embedded and non-embedded product development and automation solutions, algorithm verification, algorithm productization, and, more recently, AI algorithm verification strategies.

Anton Muzhailo, Senior Solutions Architect, Technology, GlobalLogic

Anton Muzhailo is a Senior Solution Architect at GlobalLogic with extensive experience in Enterprise Architecture and Software Quality Assurance. He holds a Master’s in Electronics and a PhD in Acoustic Engineering from Kyiv Polytechnic Institute. As a part of the GlobalLogic Technology Office, he leads technical advisories, assessments, and consulting across multiple domains. Anton has also held numerous roles in software engineering, test automation, configuration engineering, and test process management. He is an ISTQB Certified Training Provider on Foundation and an Advanced Level Test Manager.