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 ...
Category: Medical devices
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 ...
Precision, balance and clinical experience
Phase II is often the most crucial phase of clinical development. This is where the study design is ...
ISO 13485 Standard Internal Auditing Course
Do you work with medical devices and quality management? Strengthen your expertise with our ISO ...
Strengthening clinical and regulatory strategy
Our Aurevia experts had the pleasure of hosting another strategic workshop with an innovative ...