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Services

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.

EU Authorised Representative

With over 25 years of experience as an Authorised Representative (EC REP) you will benefit from our expert knowledge. Click below for more.

Regulatory & QMS Consultancy

Our experienced team of consultants understands the challenges of preparing technical documentation and quality management systems needed to successfully enter the EU market.

Regulatory Importer Service

Click below and find out how we meet the obligations of an Article 13 MDR/IVDR Regulatory Importer without disrupting your well-established supply chain.

Other Services

We offer many more services to help you reach your regulatory goals, click below to find out more.

How do we perform?

50%

Response Time

96% state that response times are within 48 hours

50%

Advice

98% agree that the advice given is helpful.

50%

Overall Performance

96% agree that Advena performs well overall

50%

Reasonable Fees

93% agree that fees are reasonable.

Statistics were taken from a 2025 client feedback survey.

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”

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Welfare Medical, United Kingdom

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”

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Endo-Therapeutics Inc., USA

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.”

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Intellijoint Surgical Inc., Canada

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”

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Artrya, Australia

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”

Aus Systems Pty Ltd., Australia
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