The MEDAGENT STORY

25 Years of Experience. Driven by Innovation.

At MEDAGENT, evolution is part of our DNA. For over 25 years, we’ve been pushing boundaries, refining our processes, and raising the bar. Our mission is simple: to combine experience with innovation, delivering smart solutions, seamless processes, and exceptional support to our customers.

Where it all began...

Local Expertise, Global Perspective

Founded in November 2000 by Nicole and Franz Menean, MEDAGENT began with a clear vision: to connect expertise, opportunity, and international markets.

The Gateway to America

In 2004, we took the next big step by establishing our US subsidiary in Portsmouth (NH). This expansion opened new doors for our customers, providing direct access to the American market and expert support for successful product launches. Today, we continue to bridge markets serving as a trusted US Agent and managing communication with the FDA. 

Turning Complexity into Opportunity

Brazil is a market full of potential. But unlocking it takes more than ambition. It takes local knowledge, regulatory expertise, and the right partner.

That’s where we come in. Since establishing MEDAGENT do Brasil Ltda. in the greater São Paulo area in 2014, we’ve been helping medical device manufacturers navigate Brazil’s complex regulatory landscape. As a Brazilian Registration Holder, we take the complexity out of regulatory approvals and help our customers turn market opportunities into real success.

A New Chapter Across the Channel

With the launch of MEDAGENT INTERNATIONAL UK LTD in December 2020, we brought our expertise to southern England, creating a direct connection to the UK medical device market. As a UK Responsible Person, we turn regulatory complexity into clarity, helping manufacturers meet UK requirements and move forward with confidence.

G’day Australia

Another continent. Another milestone. A whole new world of opportunities. In September 2025, we expanded our global footprint once again, launching MEDAGENT AUSTRALIA PTY LTD in the heart of Sydney’s thriving business hub. Our mission remains unchanged: to make international market entry easier, smarter, and more accessible. 

Because crossing borders shouldn’t mean facing barriers.

More Than a Service Provider. A Partner You Can Count On.

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.

Regulations evolve. Industries change. And we never stand still. At MEDAGENT, continuous learning is part of who we are. By investing in our team’s expertise and staying ahead of regulatory developments, we ensure our customers benefit from up-to-date knowledge and reliable solutions.

The quality of our services, reliable processes and the satisfaction of our customers are MEDAGENT’s top priorities.

"Since the company was founded, our aim has been to work together with customers from the medical technology sector as partners and to meet on an equal footing. Entrepreneurial responsibility, team spirit and diligence are among the cornerstones of our company."
Franz Menean (CEO & Senior Consultant)
Everything from a single source - always one step ahead with expertise and flexibility.

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.

Your Market. Our Expertise. Your Success.

We are "Experts in Certification". And here's what that means for you:

Market Access Made Simple

Entering new markets shouldn't feel like navigating a maze. We simplify complex regulatory requirements and help you open doors to international opportunities with confidence.

Less Red Tape, More Progress

Time matters. Our experts optimize approval processes, reduce unnecessary complexity, and help you bring your medical devices to market efficiently.

Smarter Processes = Better Results

Efficiency isn't just a buzzword for us. We identify opportunities to optimize your workflows, reduce costs, and make better use of your resources.

Global Reach Meets Local Expertise

Germany. USA. Brazil. UK. Australia. Five countries, one connected team. We combine international experience with local regulatory knowledge to support your ambitions across borders and ensure your success in global markets.

One Size Never Fits All

No two markets are the same. Neither are our customers. That's why we develop tailored strategies that fit your products, your goals, and your path to market. Your Innovation Deserves a Global Stage. Let's Make It Happen.

OUR EXPERTISE

Discover What We Can Achieve Together

For over 25 years, MEDAGENT has been helping medical device manufacturers turn complex regulatory challenges into opportunities. We know the regulations, understand the markets, and speak the language of international authorities.

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.

But expertise alone isn’t enough. We translate our experience based on recognized quality management standards into supporting 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? To help you achieve a smooth and successful market authorization by supporting you with our expertise and the resources of our global network.

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