MSc in Biomedical Engineering with general overview of the Medical Device sector and special focus on Risk Management, regulatory aspects on medical information systems and safety assessment of Medical Devices.
Until 2015-06-30 Senior expert at the Swedish Medical Products Agency. Actively participated in EU committees NBOG and COEN, represented EU in IMDRF Software as Medical Devices working Group and since long member in a number of IEC/CLC and ISO/CEN standardization committees. Trained auditor and assessor for medical device manufacturers and Notified Bodies.
Now consultant in own business, Mats Ohlson MT-Advisor, offering regulatory advice in the medical device field for manufacturers, developers, users, authorities and others.
Specialities: CE-requirements for Medical Devices, Quality Management, Risk Management, Medical Information Systems (SaMD), Standardisation, Accident investigations, Communication, Teaching