The journey of a medical device to the market and best practices

KIP
Entrepreneurship

Meeting at the Hradec Králové-based company ELLA-CS

We invite you to a professional meeting focused on the certification of medical devices and expansion into foreign markets from the perspective of companies that have conquered the world. The meeting will take place at the new facility of ELLA – CS.

Event Highlights

  • real-world case studies
  • open discussion and networking
  • tour of the ELLA-CS premises
  • expert insights into certification

Target Audience

  • companies
  • public organizations with a healthcare focus

Program

9:30 AM – 10:00 AM | Registration

10:00 AM – 10:15 AM | Opening & Introductory Remarks
Karel Volenec, ELLA-CS and Vendula Hájková, Plus inovace

10:15 AM | Pavel Kušnierik, Betthera s.r.o.MDR in Practice: How to Bring a Medical Device to the European Market
The product’s journey from idea to market launch is winding. How to see around the corner, avoid dead ends, and plan a successful medical device certification?

10:45 AM | Jaroslav Duba, OAKS Consulting / DUBA & Partners Inc.Successful Entry of a Medical Device into the US Market
A practical guide to entering the American market: from feasibility studies and FDA registration to establishing a company, obtaining support in individual US states, and evaluating financial requirements.

11:15 AM | Vladislav Polách, CzechTrade – United Arab Emirates – Support for Czech Companies
The United Arab Emirates, the gateway to the Middle East. How do the individual emirates differ, how does the local business environment work, and what steps await you when entering the market?

11:45 AM – 12:00 PM | Coffee break

12:00 PM | Matěj Misař, Carebot
The story of the Czech startup Carebot, currently the most widespread AI solution in healthcare in Central and Eastern Europe. How it managed to navigate the demanding certification process, gain the trust of regulators, doctors, and patients, and expand into global markets.

12:20 PM | Karel Volenec, ELLA-CS
ELLA-CS: How a purely Czech company conquered the entire world.

12:40 PM | Closing Panel Discussion – ELLA-CS, Pavel Kušnierik, CzechTrade, Carebot

1:15 PM | Lunch & Networking

2:00 PM | Tour of the ELLA-CS premises

Partners

Held under the auspices of

The event is held under the auspices of the Smart Accelerator+ project of the Královéhradecký Region

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