ABOUT US
OUR FOCUS
As a service provider for medical device regulatory issues, we strive to offer our customers high-quality and efficient solutions. With expert knowledge, passion and commitment, we concentrate fully on your product.
WE WORK SOLUTION-ORIENTED.
When completing our tasks, we always focus on the solution. In order to collaborate with our customers in a goal-oriented manner, we try to understand exactly what the challenge is, right from the very beginning. We will define our goals together with you and are fully dedicated to achieving them for you. As a result, you will have the time to focus on your actual work in the meantime.
WE COMMUNICATE ON EQUAL TERMS.
We communicate with a sense of appreciation. It doesn’t matter whether you are a start-up that needs a CE marking for its first medical device, for instance, or a customer with a great deal of regulatory experience - your wishes and needs are important to us. Dealing with each other in a spirit of partnership and respect is a matter of principle for us, both with our customers and also within our team.
WE ADVISE INDIVIDUALLY.
Each medical device and each manufacturer are different. Therefore, we create customized solutions, made just for you. We are also happy to come up with solutions for tricky problems. And if we do get stuck, we will find the right partner for you in our network, so that we can always help you.
WE OVERCOME DISTANCES, AND WORK FLEXIBLY.
Due to our way of working, we can overcome long distances with ease. You will find our employees in different locations across Germany, from Hamburg to Heidelberg, from Emsdetten to Berlin and sometimes even outside of Germany. Whether we work at home office, on the train or in a meeting room at your location- we are just as used to mobile working as we are to reacting flexibly to your wishes and sometimes going the extra mile for you.
WE MAKE COMPLEX TOPICS EASY TO UNDERSTAND.
As a manufacturer of medical devices, you often have to deal with complicated processes, comply with norms and standards, and consequently overcome major hurdles to introduce your product to the market. We will help you to stay on top of things, work efficiently and, at the same time, meet the regulatory requirements. As consultants, we will find the right words and strategies to create workable solutions for our customers.
WE GROW WITH EACH CHALLENGE.
We have been involved in research and clinical evaluation of medical devices for almost 20 years. And although we can build on an enormous amount of experience, we handle each new project with an inquisitive mind, a spirit of research and healthy curiosity. We, as a team, never stop learning and flexibly adapt to changing regulatory requirements. As our customer, you will benefit from our wealth of knowledge.
WE LOVE NETWORKING.
We don’t like standing still, we strive to be among the best. To ensure this, we hold in-depth consultations with our customers and also exchange ideas within the team on a daily basis. In addition to our memberships in relevant associations, we keep up to date by actively participating in industry events - both as participants and speakers. We network with authorities, notified bodies and also like to look beyond the medical device industry to broaden our horizons and gather new ideas which may benefit you as a customer.
GET TO KNOW OUR TEAM
Do you want to know what makes our consultants the best experts for you?