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Who is the stricter regulatory parent?
Medical technology is rapidly evolving, challenging regulators to maintain oversight while also encouraging innovation. The ... Continue reading...
Anything but boring: The daily life of the QA/RA team
“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
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
Medical device manufacturers often consider post-market surveillance (PMS) as an activity conducted by their regulatory ... Continue reading...
Cybersecurity for software medical devices
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?
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?
At first sight and consideration, one may say that new solutions driven by artificial intelligence ... Continue reading...