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 ...
Category: Medical devices (8)
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 ...
Swedish Medtech Regulatory Summit
The Swedish Medtech Regulatory Summit is just around the corner — taking place on March 12th at ...
Unlocking the future of medtech
Navigating the European medtech regulatory jungle? Good news—real progress is ahead. In her latest ...
Takeaways from Labquality Days 2026
The Developing Healthtech track at this year’s Labquality Days was both energizing and ...
Breakthrough devices: Key insights from MDCG 2025-9 guidance
The Medical Device Coordination Group (MDCG) has published guidance MDCG 2025-91 to streamline the ...