The MEDAGENT Story
We at MEDAGENT have been constantly evolving for over 25 years. We are constantly striving to perfect our processes and procedures so that we can provide our customers with the best possible support in all areas.
How it all began...
MEDAGENT was founded in November 2000 by Nicole and Franz Menean.
The subsidiary in Portsmouth (NH), USA, was founded in 2004 to provide our customers with access to the American market and support them in successfully launching their products on the market. We also act as a US agent and handle communication with the relevant authorities.
MEDAGENT do Brasil Ltda. was founded in the greater São Paulo area in 2014. Since then, we have acted as a Brazilian Registration Holder and provide our customers with comprehensive support in the approval and market establishment of their medical devices in Brazil.
The newest member of our group of companies, MEDAGENT INTERNATIONAL UK LTD, was founded in December 2020 in the south of England. In this role, we act as a UK Responsible Person (UKRP) and support our customers in complying with UK regulatory requirements.
Currently, over 300 MEDAGENT customers worldwide benefit from the comprehensive support of our highly qualified team of around 30 experts. In addition to consulting, we offer tailor-made solutions for process optimization, professional representative services and practice-oriented seminars to provide our clients with optimal support in meeting regulatory and business requirements.
Through continuous further training, we ensure that our team always has the latest specialist knowledge. The quality of our services, reliable processes and the satisfaction of our customers are MEDAGENT's top priorities.


Our mission statement
At MEDAGENT, we do everything we can to offer our customers not only first-class advice, but also customized solutions and the highest level of expertise. Our team of subject matter experts ensures that every challenge is tackled individually and efficiently. Through our proactive support, we go one step further - anticipating needs before they arise and providing solutions that are perfectly tailored to our clients' specific requirements.
Our in-depth industry knowledge, which we are continuously expanding, and our strong, internationally oriented network enable us to offer our clients support in all matters. In this way, we help you to reliably meet regulatory requirements and at the same time make the most of your market opportunities.
We see ourselves as long-term partners and accompany our customers through all phases of their development. Because only through committed, sustainable cooperation can the trust that is essential for successful partnerships and long-term success be created. We are proud to stand by our customers as a reliable partner - always with the aim of realizing your visions and leading you to the best possible success.
Our values
Honest work
At MEDAGENT, we attach great importance to transparency in all our actions. Integrity is the foundation of everything we do and forms the basis for the trust we invest in every partnership. We always act with respect and fairness and stand by our principles. Our approach is to offer individual solutions - not standardized concepts. We do not simply offer services, but customized, targeted solutions that are precisely tailored to the needs and requirements of our customers. We focus on the highest quality, innovation and the best possible implementation to ensure long-term success.
Reliability
With us, you can rely on maximum security and trust. Through conscientiousness, a sense of duty and responsibility, we strive together to achieve your goals. Our aim is to always offer you reliable solutions, which is why we work closely with selected, trustworthy partners. Our qualified network of cooperation partners is also at your side to optimally master your challenges and ensure sustainable success.
Independence
Our independence is an essential part of our corporate philosophy and we are determined to maintain this in the future. For us, independence means building close and cooperative relationships with third parties without being involved in "hidden" business or conflicts of interest. We recommend software solutions, certification bodies, notified bodies, technical experts, lawyers and consultants solely on the basis of sound conviction and objective assessments - never for financial or provisional incentives. We strictly reject commissions and financial kickbacks to ensure that all recommendations and collaborations are always transparent, ethical and in the best interests of our clients.
Flexibility
We are adaptable, agile and innovative - values that characterize our actions and allow us to operate successfully in the dynamic business world. The core of our company lies in efficiently solving complex challenges and developing customized strategies to successfully achieve both our own goals and those of our customers.
Team spirit
Our motivation is our team - we are not followers, but driving forces. The MEDAGENT team is the foundation of our success. Support, cooperation, solidarity and a strong sense of togetherness are the principles that characterize our daily work and drive our continuous development. We are firmly convinced that top performance begins with the quality of our employees. For this reason, MEDAGENT relies on many years of experience, continuous qualification and the targeted promotion of professional expertise. This is the only way we can meet the high standards that both our customers and we ourselves demand.
We are "Experts in Certification"
Smooth market access
The comprehensive understanding of global regulatory requirements enables smooth and efficient market access.
Efficient approval
Our experts optimize the approval process to bring your products to market efficiently and in a targeted manner.
Process optimization
By making targeted improvements to your processes, we help you to reduce costs and make optimum use of resources.
Global presence
With our branches in Germany, the USA, Brazil and the UK, we provide you with comprehensive expertise to ensure your success in global markets.
Individual solutions
We develop tailor-made strategies to optimize market access in various international markets.
Benefit from over 25 years of expertise
Our focus is on the medical device industry and we have extensive expertise in implementing and complying with international regulatory requirements that are critical to success in global markets. We offer you in-depth support in meeting complex regulations and standards worldwide to ensure that your products meet the highest quality and safety requirements. Through our many years of experience in working with international authorities and applying best practices in medical technology, we are able to provide you with customized solutions that meet the specific requirements of each market.
In addition, we use our experience based on recognized quality management standards to support you not only in meeting regulatory requirements, but also in optimizing your internal processes. This holistic approach helps to ensure the quality of your products while increasing your efficiency and competitiveness. Our goal is to help you achieve a smooth and successful market authorization by supporting you with our expertise and the resources of our global network.