Mr. Ginsberg specializes in software regulatory issues relating to medical devices and modern software engineering methods, for example Scrum or Lean Software development. He has through the years worked with resolving potential issues with aligning the regulations and iterative software development methods. Robert has an physics/engineering background, and has implemented modern software engineering methods at several medical device companies, large as small. He has the last 16 years been an active member of international standardization committee, developing IEC 62304 and IEC 82304-1 and more. He is also currently a 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.