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EU Authorised Representative, Regulatory & Quality Consultants for Medical Devices

EU Authorised Representative, Regulatory & Quality Consultants for Medical Devices

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.

Don’t just take our word for it…

Latest EU Medical Device News

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. We are exhibiting at the following events: