KIP at the Hradec Králové-based company ELLA-CS dedicated to the healthcare and certification sector

International markets favor the prepared

How to manage regulations and succeed in foreign markets with medical devices? This is exactly the question we sought to answer during the latest Regional Innovation Platform at ELLA-CS, with nearly 45 representatives of medical device manufacturers from across the Czech Republic.

The meeting demonstrated that a well-set strategy and the sharing of practical experience can significantly facilitate the path to international markets.

Discussions and practical recommendations

The discussion provided very specific insights into key areas:

  • how to approach MDR in practice and prepare a product for the European market – Pavel Kušnierik
  • what entering the US market entails from the FDA perspective and how to prepare for its specifics – Jaroslav Duba
  • how to think about markets such as the United Arab Emirates and what to expect there – Vladislav Polách

Examples directly from practice also held great value. The experience of the startup Carebot, which is successfully expanding abroad, was presented by Daniel Kvak. Practical recommendations from ELLA-CS, s.r.o., which has a history of numerous successful entries into foreign markets, were then presented by the company’s director, Karel Volenec.

Production tour

The entire meeting was perfectly framed by the environment of ELLA-CS, s.r.o., where the event took place and where participants had the opportunity to get a behind-the-scenes look at the production of unique biodegradable stents.