Anything but boring: The daily life of the QA/RA team
July 20, 2022
“I never thought I’d work in regulatory affairs.” Everyone in Quality Assurance or Regulatory Affairs ... Continue reading...
How to move fast and not break things
January 14, 2022
On May 26th 2021, the EU Medical Device Regulation 2017/745 (MDR) passed the date of ... Continue reading...
A new era of post-market surveillance for AI medical solutions
April 13, 2021
Medical device manufacturers often consider post-market surveillance (PMS) as an activity conducted by their regulatory ... Continue reading...
Cybersecurity for software medical devices
October 29, 2020
In our previous regulatory article about 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...