Robert Ginsberg Principal Consultant and Chairman of the Board
Robert has 25+ years of experience of software development, and the entire chain for product development, Agile, Lean and quality assurance in Medtech environments. He has implemented modern software techniques and methods at several companies. He is often engaged to conduct product and software risk analyses, improve way of working and find and efficient level of compliance.
Robert holds an MSc in Technical Physics from Uppsala University and is Certified Lead Auditor (ISO 13485 and QSR). He is a member of the Swedish national standardization committee for IEC 62304 and related standards. He is a member of EU Commission MDCG working group for New Technologies incl. software and cybersecurity.
“Can we work in an iterative way in a regulated environment?” ”Yes, Lean and regulatory expectations can go hand in hand. My mantra is to work iteratively in small steps, gaining feedback and continually improve the way of working. Always start with the vision where to go, taking baby steps in that direction. Concentrate your efforts where there is the highest potential to leverage quality and value. At the end you will notice that iterative techniques can improve compliance, quality and time-to-market of products.”