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Quality improvement in theory and practice: guiding principles and a real-world incident fix
July 20, 2021
As a clinician, I was always interested in quality improvement. I enjoyed the logic of ... Continue reading...
A new era of post-market surveillance for AI medical solutions: live performance monitoring
April 13, 2021
PMS as a collaborative effort Medical device manufacturers often consider post-market surveillance (PMS) as an ... Continue reading...
Cybersecurity for software medical devices: An overview of regulatory frameworks
October 29, 2020
In our previous regulatory article around the introduction of the MDR and its impact on ... Continue reading...
Will the MDR improve regulatory oversight of AI solutions?
June 30, 2020
The regulatory frameworks are often unclear when it comes to software as a medical device, ... Continue reading...
Regulations are rapidly evolving, but do they match technology?
May 8, 2019
At first sight and consideration, one may say that new solutions driven by artificial intelligence ... Continue reading...