About Us

Our Methodology

At ECURAC, we believe that each medical device is unique. Our approach is to communicate with regulatory agencies, to identify the requirements applicable to your unique device and to communicate them to each regulatory agency and to develop the regulatory strategy that works best for your specific product in order to offer you the most accelerated market approvals.

Our Expertise

ECURAC consulting provides technical expertise on regulatory strategy planning, regulatory agency guidance interpretation and market approval submission for medical device products in Europe, China and US.

The ECURAC team consists of leading industry professionals with years of experience. Our experts have strong technical backgrounds and in depth understandings of medical device regulations. With ECURAC, we assist our clients on all levels of regulatory submission processes, including strategic regulatory development, product testing, regulatory submission filing, and communications management with regulatory agencies. Our goal is to help you achieve regulatory approval as quickly and efficiently as possible, in order to enter the international market.

Our Focus

ECURAC experts in Europe, China, and US and can offer hands-on support for your regulatory needs throughout our global network. Our experts are knowledgeable with regional medical device regulations and well connected with local regulatory agencies, reviewers, and certified testing labs and industry associations. ECURAC focuses on delivering excellence in regulatory affairs support for medical devices licensing and regulatory compliance activities.