Control your measuring and monitoring equipment
Compliance with ISO 13485 and EU MDR/IVDR require clear evidence of effective control over ...
Author Aurevia:
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 ...
New EU regulation for compliance with EUDAMED
EU Regulation 2024/1860 includes an amendment to the MDR & IVDR regarding a gradual rollout of ...
Welcome Melanie and Daniel!
We are pleased to introduce two new team members who will be strengthening our efforts in the Sales ...
Labquality strengthens its clinical trials service business
Labquality, supported by Mérieux Equity Partners, acquires Scandinavian CRO. Labquality Corporation ...
Is clinical data needed in a 510k
In most 510(k)s the FDA does not require clinical data, and class 1 devices are generally exempt ...