Collaborating with the life sciences and medical technology companies as well as health care providers in Quality Management, Risk Management, Cyber Security, Type Approvals, Audits, etc. in the USA and in Finland.
Focus for the last 25 years has been developing quality management systems in start up or early stage organizations. Have extensive experience with Canadian Medical Device Regulations, FDA QSR, EU Medical device directive and the upcoming EU MDR and other international regulatory agencies. Considerable experience with validations, sterility and sterilization, implementation of automated systems including ERP and LIMS, and project management. Also act as a representative for Canada on the ISO committee for Medical Devices.