Simon Sjöhage is a quality and regulatory consultant at Key2Compliance®.
Simon has a MSc in in Engineering and a bachelor- and master’s degree in medical engineering.
He has experience as QA-manager at class I and II product manufacturing and research companies. QA-officer at manufacturing factory of class III product, ISO 13485, product release, non-conformities, CAPA and complaint handling as well as maintaining the quality system. Product development working with IEC 60601-1, -1-8 Alarms and -1-6 Usability (including IEC 62366 and IEC 62366-1). He has also implemented UDI on several products at several companies.
