European Union Services

Advena Ltd.’s headquarters in the United Kingdom can assist your company

with registration and representation of your medical devices in the European

Union by providing the following services:

- EU Authorised Representative

- Technical File Preparation

- Product Registration

- Quality System Development

- ISO 13485 inspection and response

- CE Marking

- Medical Translations

- Monthly regulatory updates

Why choose Advena Ltd. to assist you in preparing your device for sale in the

European Union?

- Personal service

- Competitive rates

- Flexible terms

- 25 years experience

- Dedication to your success

- Support for both EU and US regulations

- Member of the European Association of Authorised Representatives