The FDA is being restructured and the world is holding its breath
For nearly 30 years, the U.S. Food and Drug Administration has played a pivotal role in shaping the ...
Health technology assessment regulation
The Health Technology Assessment Regulation (HTAR), officially known as Regulation (EU) 2021/2282, ...
Anna-Karin Alm
QAdvis is delighted to announce that Anna-Karin Alm has joined QAdvis as the new CEO, effective ...
May your holidays be full of warmth and cheer
We at QAdvis want to wish you a joyful holiday season and say thanks for what we have achieved ...
Control your measuring and monitoring equipment
Compliance with ISO 13485 and EU MDR/IVDR require clear evidence of effective control over ...
The importance of a robust design and development dd process in medical device companies
Human Factors Engineering (HFE) or Usability Engineering (UE) isn’t just about functionality and ...
Urgent need to revise the MDR
The EU Commission is urged to propose solutions by no later than the end of Q1, 2025. The revisions ...
A part of Labquality
QAdvis continue the collaboration with Labquality and will formally merge with them in the ...
PMS is not a new requirement
People often talk about the Post Market Surveillance (PMS) requirements in the Medical Device ...