Software, Artificial Intelligence and Cybersecurity in the European Union
27 Min
1 Lesson
Price
$75 Per person
Lecturer
Robert Ginsberg
EAAR Member of the Board, Chairman of the Board, QAdvis, Sweden
Robert Ginsberg is co-founder and Chairman of the Board of QAdvis, a Sweden based consulting company in medical device regulations. He specializes in software regulatory issues relating to medical devices and modern software engineering methods, tools and technologies, for example agile methods, continual deployment or artificial intelligence.
He has through the years worked with resolving potential issues with aligning the regulations and iterative software development methods. Robert has a Master’s degree in physics and engineering, and has implemented modern software engineering methods at several medical device companies, large international as well as small start-ups. He has the last 18 years been an active member of international standardization committee, developing IEC 62304, IEC 82304-1, IEC 81001-5-1 and more. He is also an active member of the European Commission’s Medical Device Expert Group for Software.
Robert is currently working as a consultant helping medical device companies finding cost effective implementation of regulations for medical device software.
He has through the years worked with resolving potential issues with aligning the regulations and iterative software development methods. Robert has a Master’s degree in physics and engineering, and has implemented modern software engineering methods at several medical device companies, large international as well as small start-ups. He has the last 18 years been an active member of international standardization committee, developing IEC 62304, IEC 82304-1, IEC 81001-5-1 and more. He is also an active member of the European Commission’s Medical Device Expert Group for Software.
Robert is currently working as a consultant helping medical device companies finding cost effective implementation of regulations for medical device software.
Description
A brief overview of regulatory requirements for medical device software according to MDR 2017/745, and IVDR 2017/746. Challenges qualifying and classifying medical device software, for example rule 11 in Medical Device Regulation. Strategies on how to successfully migrate to MDR and IVDR, having in mind new challenges and technologies, for example Cybersecurity or Artificial Intelligence.
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