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 ...
Labquality acquires QAdvis AB
Labquality strengthens its regulatory affairs service capabilities and expands to Sweden. ...
Free Seminar – Incident Reporting/PMS – 19 June – Kista
Let’s talk about incident reporting, one of the important Post Market Surveillance activities for ...
Leveraging clinical quality registries for innovative clinical trials
Innovation in clinical trials is vital for the future of medical research and development, and ...
Free Seminar – Incident Reporting/PMS – 13 June – Lund
Let’s talk about incident reporting, one of the important Post Market Surveillance activities for ...
Will AI replace your doctor?
AI enabled medical devices are increasingly making their way into every sector of the medical ...