Brita is an expert in medical device regulations (MDD/MDR) and has a long experience of use and maintenance of medical devices in the health care environment.
She has a long regulatory background and has worked for the Swedish Medical Products Agency (MPA) for the last 12 years. Brita has worked with inspections of manufacturers, and she has been auditing notified bodies in Sweden. She has also participated as a national expert for the Commission in the work of assessing notified bodies according to MDR in other member states in Europe.
At the authority she has also been working with supervision of post market surveillance and vigilance systems. This included reviewing quality management systems and risk management processes of medical devices.
Beside the experience at the authority, she has a broad clinical background which means that her strength lies in knowledge of usability and to detect and define risks. Brita has worked as a nurse in several different types of hospital wards. She is also a biomedical engineer by training and has worked with repairment and maintenance of different medical devices at hospitals. This makes her aware of the technical issues affecting performance and safety of the devices.
Brita has also experience of working with procurements at county council being responsible for purchasing medical devices for hospitals and dispensaries.
The main goal for Brita is to find solutions for medical devices that are safe, fit for purpose and regulatory compliant.
Brita’s experience within medical devices will be a great contribution to broaden the competence and expertise within RegSmart!