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…
We really appreciate Advena team’s quick and accurate support.
We really appreciate Advena team’s quick and accurate support. We look forward to working you going forward.
You guys are the best, as always providing service, support and partnership
Thank you so much! You guys are the best, as always providing service, support and partnership. Much appreciated.
Solid answers to our most challenging regulatory questions
We have been with Advena Ltd since 1998 and view them as a real friend to smaller companies trying to navigate the ever changing regulator… “Solid answers to our most challenging regulatory questions”
Knowledgeable and quick to respond
We shifted over from an alternate authorised rep a few years ago and the service provided by Advena far exceeds the service provided by the… “Knowledgeable and quick to respond”
The help and assistance given from Advena has been excellent, and I’ll be happily quoted on that.
Thanks for this, absolutely perfect, and should i add, although the journey to CE marking has been somewhat tricky, the help and assistance given from… “The help and assistance given from Advena has been excellent, and I’ll be happily quoted on that.”
Just keep doing what you’re already doing
Just keep doing what you’re already doing, fantastic job.
Outstanding and we look forward to utilizing your services.
Outstanding and we look forward to utilizing your services.
I love working with Advena
I love working with Advena, super easy and they are great communicators
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.”
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”
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”
Overall, Advena provide excellent customer service
Overall, Advena provide excellent customer service, are very prompt and most importantly are transparent. Advena are a credit to the regulatory sector.
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”
Service was done in a timely manner and was more than expected!
Service was done in a timely manner and was more than expected! Good communication was maintained throughout each project.
We really enjoy the newsletters.
We really enjoy the newsletters. They provide timely and helpful information for our team.
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”
Provided excellent guidance
We truly appreciate the cooperation and patience of the Advena staff. They have provided excellent guidance in helping us decide on the best course of… “Provided excellent guidance”
The newsletter is excellent.
The newsletter is excellent, extremely informative and clearly laid out
Latest EU Medical Device News
UPDATE: MDCG 2020-16 rev.5: Guidance on Classification Rules for In Vitro Diagnostic Medical Devices under Regulation (EU) 2017/746
The Medical Device Coordination Group (MDCG) has updated its guidance on the classification of in vitro diagnostic medical devices (IVDs) under Regulation (EU) 2017/746 (IVDR). ...
Upcoming Events
As part of our commitment to engage with clients, we attend medical industry exhibitions and events all over the world. If you are interested in our services, or you are an existing client, come meet us.
