Investigator-initiated clinical trials
Many important clinical studies start with researchers – not pharmaceutical companies. In ...
Category: News
A new global standard for clinical evaluation is on the horizon: ISO/DIS 18969
A new global standard for clinical evaluation is on the horizon: ISO/DIS 18969. The core message is ...
Clinical trials: proposals, budgets, and the evolving CRO role
This podcast episode from Trustful Clinical Budgeting dives into what really makes proposals work ...
A big milestone for the MINT study
After nearly four years of coordinated, hands on work across sites and functions, the MINT study ...
Quality management system according to EN ISO 13485:2016 – in practice
Do you work with medical devices? Understanding and implementing a robust Quality Management System ...
How MoniDose strengthened their regulatory confidence—fast
When MoniDose began their startup journey, regulations were their biggest challenge. Missing early ...
Expert spotlight: Cristina Albu Barkman
Today we’re celebrating one of Aurevia’s most experienced specialists: Cristina Albu Barkman, who ...
Are you prepared for the updated ISO 10993 -1:2025?
The latest edition of ISO 10993-1 reinforces the integration of biological evaluation with risk ...
Transport validation for medical devices
According to MDR 2017/745, “Devices shall be designed and manufactured in such a way as to ensure ...