15/08/2019 – Gert-Jan was invited to speak at the Future of Human Factors in Medical Devices Congres in London. He discussed the learning from incidents process under the new MDR.
The new MDR requires manufactures to play an active role during the post-market phase by systematically and actively gathering user experiences. After launching, users will use your medical devices within different local work environment and processes. Together with the attendees, Gert-Jan dove into the world of human factors adverse event (vigilance) investigation. He used the concept of distributed situational awareness to streamline the learning from events process. Gert-Jan is convinced that Post Market Surveillance will not only stimulate safe design for manufacturers, but also a much safer organisation of work processes and local circumstances within Health Care Organisations.
If you want to know more about the learning from events process or our Medical Device Regulation services, please e-mail Gert-Jan Kamps or call +31618623586.