Qserve will open a Germany office in June 2018, located in Karlsruhe and will be represented by Dr. Stefan Menzl who is a member of Qserve’s global team since October 2017.
1. With the opening of the German office, will Qserve focus on the German market only?
Germany has a number of small and medium-sized enterprises (SME's) in the MedTech sector. Qserve wants to support SME's with practical solutions. Our team in Germany can support all German-speaking countries (DACH). Germany is an ideal location to also support MedTech companies in surrounding countries like Switzerland, Austria, Italy and other countries. With our headquarter offices located in Arnhem, the Netherlands, and the new office in Karlsruhe, Germany, we are well located to easily reach customers based in any European country. The diversity of our team brings additional advantages, one of them is that we speak 21 languages.
2. Qserve is specialized in the Medical Devices & In-Vitro Diagnostics Regulations. What do you think we can offer to our German (speaking) customers?
The medical device regulations are becoming increasingly difficult. It will be hard to deal with the changed requirements for medical device regulatory compliance. Qserve intends to be the global partner for Medical Device Regulatory Compliance. Our benchmark is the unique combination of a global reach, high-level expertise, and staff with field experience. Our consultants had former positions at medical device manufacturers, European Notified Bodies, US FDA or Chinese CFDA.
Our mission is to support all medical device manufacturers with a practical approach, translating existing regulations to understandable requirements.
We offer full service in the area of Global Registrations, Regulatory Compliance, Clinical Affairs including the service of our own CRO, Quality Management, Auditing, and Training.
3. How would you describe the German medical devices market?
Medical devices “made in Germany” make a significant contribution to enhancing patient health and quality of life around the world. Medical technologies developed in Germany benefit from a world-class research and business environment, with the sector’s predominantly small and medium-sized companies enjoying an international reputation as innovators and market leaders. The medical technology sector in Germany is an important driver of the economical
progress. On average, MedTech companies invest 9% of their turnover in research and development. The export share is at 65%. The sector is characterized by small and medium-sized companies. 92% of companies have less than 250 employees. In total, the Medtech employs about 210.000 fte
(source BVMed). Read more facts & figures here
4. Which opportunities do you see for the German medical devices market?
With its state-of-the-art infrastructure and its central location in Europe, Germany is an ideal location for serving surrounding European countries with a potential market volume of more than EUR 1,300 billion. Medical technology “Made in Germany” is highly valued around the world. Although the US remains the largest single market and demand from China continues to grow, the largest share of German exports stays within Europe.
German medical technology is cutting edge. Hundreds of companies – nearly all of them medium-sized – produce medical technology innovations across the entire spectrum of products. Many specialize in very specific fields of applications or types of products. While these companies may focus on niche markets, they are often world market leaders in their respective fields. With the stricter regulatory requirements and scrutiny, German MedTech manufacturers will have to invest in compliance. That is where we want to support.
5. How can Qserve support MDR compliance?
Qserve is a “one-stop shop” for medical device companies that are looking for support in any of the following areas: Regulatory Compliance, Clinical Evaluation, CRO, Quality Management, Training
and Global Registration
One of our most requested services at the moment is helping our clients to stay in compliance throughout the transition into the new European MDR regulation
. Together with the client, we develop and execute a customized Roadmap to EU-MDR Implementation
6. Why Qserve?
Qserve offers the “practical approach”, meaning we offer very pragmatic solutions customized to the specific needs of our clients. Our unique combination of a global reach, high-level expertise, and staff with field experience. With our strong international team with technical, regulatory, quality, clinical and CRO competence combined with a global presence and local service and the knowledge of understanding the German culture.
7. What do you hope to achieve in the next few years?
I like to significantly contribute to the sustainable success of our current and future clients. Helping to improve the life of patients, sometimes even saving their lives has been my greatest motivation throughout my entire professional life in Medtech-industry.
Supporting great companies to bring new technologies to the market quickly and most efficiently and with that increasing quality of life, secure health and safety and make sure that proven established technology will remain available to patients is what I want to do with Qserve.
I want to offer Medtech companies Qserve’s practical approach, help them grow and develop and with that make Qserve one of the leading consulting companies in Germany.
Should after reading you want to know more, then by all means, get in touch with me or the Qserve team. We are always happy to talk and support!