Publication of Regulation (EU) 2022/112
–A Risk based roll-out plan for certain In Vitro Diagnostic medical devices and In-house devices On ...
Author Aurevia:
Clinical Trials Regulation (CTR) (Regulation EU No 536/2014)
The Clinical Trials Regulation (CTR; EU No 536/2014) will replace the EU Clinical Trial Directive ...
Welcome to QAdvis!
We are very pleased to welcome a new consultant, Nils Lidström to our QAdvis team! Nils has a ...
Initiative for Accelerating Clinical Trials in the EU (ACT EU)
The European Commission (EC), Heads of Medicines Agencies (HMA) and the European Medicines Agency ...
We wish all our customers and partners a Merry Christmas and a Happy New Year!
Every day a child is diagnosed with cancer. But there is hope. More children than ever survive ...
Christmas Rhyme 4th Advent
Internal Audit (ISO 13485:2016 clause 8.2.4) The fourth of advent is finally here, and Santa is ...
QAdvis News #4 – 2021
Great possibilities ahead! Just like 2020, 2021 has been a different and eventful year in many ...
Christmas Rhyme 2nd Advent
Management responsibility (ISO 13485:2016 clause 5) The second of advent is coming up have the ...
Christmas Rhyme 3rd Advent
Risk Management in Product realization (ISO 13485:2016 clause 7.1) Managing risk plays an important ...