Michael Asmalsky holds a master in business engineering from the University of Karlsruhe, Germany, nowadays K.I.T. – Karlsruhe Institute of Technology and a master in industrial economics from the University of Aix-Marseille, France.
He worked for more than 20 years in regulatory affairs and was responsible for worldwide regulatory approvals of medical and non-medical devices, including among others the USA, Canada, the EU, China and Japan.
He is a member of ISO TC 210 JWG1 on the application of risk management to medical devices and one of the authors of ISO 14971 and ISO 24971. He is responsible for the Risk Management Process and the Usability Engineering Process of Philips Hospital Patient Monitoring Business.