FDA 21 CFR Part 820 is now the Quality Management System Regulation (QMSR). The final rule was published in the
The Medical Device Regulation (EU) 2017/745 (MDR) has applied since 26 May 2021, yet software manufacturers are still working through
We are pleased to welcome Eva Kurilova-Sahin to the MedQAIR team. Eva brings a background in medicine, clinical science, radiology,
Post market surveillance (PMS) for medical devices is the system a manufacturer uses to collect and analyse data on its
The EU declaration of conformity is usually the shortest document in a medical device file, and it is often the
When Regulation (EU) 2017/745 (MDR) started to apply on 26 May 2021, it brought in Rule 11, a classification rule
The regulatory landscape for medical devices is becoming more complex as artificial intelligence becomes part of diagnosis, monitoring, treatment, and
Regulation (EU) 2017/745, the Medical Device Regulation (MDR), was adopted on 5 April 2017 and has applied since 26 May
In the United States, section 513 of the Federal Food, Drug, and Cosmetic Act sets a risk-based system of three
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