We accompany your team from the idea to the regulatory approval of your medical device
INDIVIDUAL - COOPERATIVE - EFFICIENT
We, the MEDAGENT team, are your partner in the areas of quality management, regulatory requirements, process as well as software validation around medical devices. With our offices in Germany, USA and Brazil, we offer qualified services and regulatory expertise in international markets.
We accompany our customers with enthusiasm from the idea to the regulatory approval and registration of your establishment and medical devices and are available with advice and support throughout the entire product life cycle.
Our Representative Services for International Registration
You are looking for a trustworthy partner to make your products available on the market with the greatest possible flexibility; however, you do not have the necessary network or knowledge of regulatory requirements for market approval?
Then we are the right contact for you! – Through our branches and representative services, we handle the approval process and act as a correspondent, responsible person with the national Competent Authority at your side.
FUTURA - MDR Compliance by Subscription
Start now with FUTURA – the digital solution for medical device manufacturers for the smooth provision of technical documentation according to MDR (EU) 2017/745.
Are you compliant with MDR requirement, but looking for a solution that will save you time and money and keep you compliant in the future?
- Fast track to MDR compliance
- Always up-to-date and complete
- Future-oriented and time-saving
Newsletter
As a manufacturer of medical devices, contract manufacturer or service provider, you would like to receive current information on directives and laws and always be up to date without having to sift through a multitude of sources?
In our newsletter we inform you regularly about current developments in these areas. Register now without any obligation!