Robert Ginsberg
Robert Ginsberg is a Senior Principal Regulatory Consultant and co-founder of QAdvis, a Sweden-based consulting firm specializing in medical device regulations. He is recognized for his expertise in software regulatory issues and the application of modern software engineering methods, tools, and technologies—ranging from agile practices and continuous deployment to artificial intelligence.
Throughout his career, Robert has focused on bridging the gap between regulatory requirements and contemporary software development practices. He holds a master’s degree in physics and engineering and has successfully introduced modern engineering methods at both global medical device corporations and innovative start-ups. For more than 20 years, Robert has been an active member of international standardization committees, contributing to the development of key standards such as IEC 62304, IEC 82304-1, and IEC 81001-5-1. He also serves as a member of the European Commission’s Medical Device Expert Group for Software.
Today, Robert supports medical device companies in achieving cost-effective, compliant implementations of regulations for medical device software.
Aiheet
European framework on cybersecurity and new technologies
A brief overview of cybersecurity regulatory requirements for medical device software under MDR 2017/745 and IVDR 2017/746. The session will highlight the challenges of achieving compliance while navigating the complex landscape of standards and guidelines issued by regulators and other organizations. It will also provide a short walkthrough of the key medical device cybersecurity standard IEC 81001-5-1 and the technical report IEC TR 60601-4-5.