Martin Stofanko has a PhD in Immunology and MSc in Applied Genetics from University of Birmingham. Following Postdoctoral work at University of Cambridge he moved into industry in Brazil developing genetic tests for their low budget public healthcare system.
He is experienced in defining, executing and writing up quality assurance and technical documentations for IVDs and up to class IIa sterile MDs in the UK, Brazil and Germany. He has lead validation, external testing and transfer to manufacturing activities within company and outsourced abroad. He has established and extended ISO 13485 QMS from D&D to manufacturing, sales and distribution.