Meeting at the ELLA-CS premises
A meeting held at the premises of ELLA-CS was dedicated to the question of how to navigate the medical legislation environment and prepare a company for successful expansion.
The event brought together nearly 45 representatives of medical device manufacturers from across the Czech Republic. The common theme was how to correctly approach regulations, prepare a product for European and non-European markets, and leverage the experience of those who have already successfully navigated this path.
A well-set strategy, knowledge of specific requirements, and open sharing of practical experience can significantly facilitate the journey of Czech companies into international markets.
Renata Říhová
RIS3 Manager
From European MDR to the American FDA
The program offered very specific insights into the key areas that medical device manufacturers encounter during expansion.
Pavel Kušnierik spoke about the practical handling of the European MDR regulation and product preparation for the European market. His presentation focused on how to approach regulatory requirements systematically and how to reflect them in actual product preparation.
The European context was followed by Jaroslav Duba, who introduced participants to entering the US market from the FDA perspective. The American environment has its own specifics, and successful preparation requires not only knowledge of the rules but also the ability to plan ahead and adapt the entire market entry process accordingly.
Another perspective was brought by Vladislav Polách, who focused on markets such as the United Arab Emirates. He explained to the participants how to think strategically about these destinations, what requirements companies can expect, and why it is important not to underestimate the local context.
Practical experiences of companies already expanding
Examples directly from corporate practice were of great value. Daniel Kvak shared the experience of the startup Carebot, which is successfully expanding abroad and demonstrating that even young technology companies from the Czech Republic can hold their own on the international stage.
He was followed by Karel Volenec from ELLA-CS, a company that has numerous successful entries into foreign markets under its belt. His experience offered participants the perspective of an established company that has long been active in the field of medical devices and is able to integrate development, production, regulations, and commercial strategy.
The inspiring environment of ELLA-CS
The entire meeting was perfectly complemented by the environment of ELLA-CS itself, where the event took place. Participants had the opportunity to get a glimpse into the production of unique biodegradable stents and see what a top-tier Czech company that can succeed beyond borders looks like.
It was precisely the connection of the professional program with specific corporate reality that gave the event a strong practical dimension. The discussion was not just conducted on a general level but was based on real experiences, challenges, and decisions that companies face when entering foreign markets.
Sharing experience as a path to success
The meeting confirmed that regulation does not have to be just an obstacle. If correctly understood and integrated into the company’s strategy, it can become an important part of successful expansion.
We thank all speakers and participants for the open sharing of experiences, specific practical insights, and inspiring discussion. It is precisely such meetings that help Czech companies better navigate the regulatory environment, prepare for entry into foreign markets, and strengthen their competitiveness on a global scale.
