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QMS for SaMD

Implementing a Quality Management System (QMS) under ISO 13485 for SaMD? It’s a whole different ballgame than dealing with hardware products! 🎮 But fear not—our

Meet Our Team- Elisabeth Sadka

With over 25 years in the medical device industry, Elisabeth Sadka, M.Sc., MBA, leads HaMaDa Consulting’s Regulatory Affairs (RA), Quality Assurance (QA), and Clinical Writing