Custom regulatory and clinical strategy workshops
A strong regulatory and clinical strategy early on can save months of rework later. Our custom ...
Category: Medical devices (2)
Are you our next Quality and Regulatory expert?
We are looking for experienced medical device or IVD Quality Assurance & Regulatory Affairs ...
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 ...
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 ...