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How to move fast and not break things
On May 26th 2021, the EU Medical Device Regulation 2017/745 (MDR) passed the date of ... Continue reading...
The delicate balance between data protection and availability
I recently got to say the four magic words: graduated and a job! My master’s ... Continue reading...
Quality improvement in theory and practice: Guiding principles and a real-world incident fix
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
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
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?
The regulatory frameworks are often unclear when it comes to software as a medical device, ... Continue reading...
Read, watch, listen: Recommendations from the Aidence team
Meta-learning for medical imaging: where are we after ICML Theranos: a cautionary tale for medical ... Continue reading...
Regulations are rapidly evolving, but do they match technology?
At first sight and consideration, one may say that new solutions driven by artificial intelligence ... Continue reading...