Articles by:
Leon Doorn

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...

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...

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