We Help Carry the Burden of Responsibility with Cost-Effective Regulatory Services
Our clients are central to our business, we provide support and assistance that helps our clients navigate the complexities of the EU Medical Device and In vitro Medical Device Regulations, opening the gateway to the EU market.
Don’t just take our word for it…
Fully professional and supportive
I have worked with Advena on the Regulatory side of our business now for more than 10 years. The service provided during this time has… “Fully professional and supportive”
Very positive experience.
Always responsive and willing to work with us. Has gone above and beyond on a number of occasions, and that has been very helpful when… “Very positive experience.”
Well informed
Advena have acted as the EU representative for Aus Systems Pty Ltd since 2005. I have always found John and his team quick to respond… “Well informed”
Quality of services
I have used Advena as part of another company and I have contracted them again for the quality of services and reasonable fees. The newsletter… “Quality of services”
Professional service and quick response
We have been using Advena Ltd. as our EU Authorised Representative since 1998 and have been very pleased with the professional service and quick response… “Professional service and quick response”
Latest EU Medical Device News
New Delegated Acts under the MDR Introduce Targeted Relief for Well-Established Technologies
Two new delegated acts under the EU Medical Device Regulation (MDR)—C (2026) 1798 and C (2026) 1809—have been adopted, introducing important updates for manufacturers of ...
