International Conference

MDR / IVDR QUALITY DAYS 2026

14. - 17. DECEMBER 2026

Grand hotel Permon****, Podbanské, Slovakia

231 days
14 hours
37 minutes
52 seconds
Request invitation

Programme

Conference programme

Participant registration

On the 8th floor in front of the PANORÁMA hall on Monday, 14 December 2026, from 13:00 to 17:00.

Dress code

Semi formal

Catering during the conference

On 14 December 2026, catering begins with lunch from 13:00 to 15:00.

Restaurant on the 7th floor: breakfast 7:00 - 10:00, lunch 13:00 - 15:00, dinner 17:30 - 21:00.

Monday 14.12.2026

Lunch in the restaurant with a panoramic view of the High and Low Tatras, 7th floor

Participant registration on the 8th floor, in front of the PANORÁMA hall

Dinner in the restaurant with a panoramic view of the High and Low Tatras, 7th floor

Evening reception with musical accompaniment

Festive opening speech - Ing. Katarína Tomin Srdošová, PhD. - Director of NB 2265, Chairwoman of the Board of 3EC International a. s.

The opening, Company Introduction

Katarína Tomin Srdošová

Changes in ISO 19011:2026, ISO 9001:2026

Katarína Tomin Srdošová

Certification process according to MDR / IVDR in KARAT software

Tomáš Polák

Coffee break

EUDAMED

Eva Rýdlová

Cybersecurity in MD: Medical Devices and AI

Radek Blaško

Understanding MDR Technical Documentation - The Key to Success (Part 1)

Juraj Šalgovič

Lunch Break, 7th floor

Understanding MDR Technical Documentation - The Key to Success (Part 2)

Juraj Šalgovič

Understanding IVDR Technical Documentation - The Key to Success

Juraj Gašparovič and Adriana Krásna

Open Discussion

Requirements regarding information supplied with the device

Slavomír Damin and Juraj Gašparovič

Devices incorporating medicinal products and biological materials

Ján Slúka

Coffee break

Benefit-Risk Analysis and Risk Management, Usability

Karol Jedlovský

Performance evaluation according to IVDR

Juraj Gašparovič and Janka Šepeláková

Lunch Break, 7th floor

Clinical evaluation under MDR & PMS

Juraj Šalgovič, Daniela Král and Michal Hronský

Most common non-conformities during audits

Slavomír Damin

Open Discussion and closing remarks

Breakfast at the restaurant

Room Check-out

Wellness access available until 16:00

Speakers

Meet our experts

Katarína Tomin Srdošová

Katarína Tomin Srdošová

Director of NB 2265, Chairwoman of the Board 3EC International a. s.

Ján Slúka

Ján Slúka

MDR Manager

Janka Šepeláková

Janka Šepeláková

IVDR Manager

Eva Rýdlová

Eva Rýdlová

Back Office & Client Support, EUDAMED

Juraj Šalgovič

Juraj Šalgovič

MDR / IVDR Clinical Evaluation Manager

Daniela Král

Daniela Král

Project Leader

M

Michal Hronský

Product reviewer MDR

Juraj Gašparovič

Juraj Gašparovič

Product reviewer IVDR & Auditor

Radek Blaško

Radek Blaško

Slavomír Damin

Slavomír Damin

Product reviewer MDR & Auditor

K

Karol Jedlovský

Product reviewer MDR

Tomáš Polák

Tomáš Polák

IS Karat Admin

A

Adriana Krásna

Transport

How to get to the conference

Most participants will arrive independently. An airport transfer is available for arrivals by plane, and a hotel transfer is available from Liptovsky Mikulas railway station for arrivals by train.

Free parking

Own transport

If you arrive by car, free parking is provided as part of the accommodation directly at the hotel.

  • Grand hotel Permon****, Podbanske, High Tatras
179 EUR incl. VAT

Airport transfer

Organized air-conditioned bus transfer from Vienna-Schwechat Airport via Bratislava to Grand hotel Permon**** and back.

  • 14 Dec 2026: VIE [AT] > BA [SK] > Permon [SK]
  • 17 Dec 2026: Permon [SK] > BA [SK] > VIE [AT]
Free of charge

Hotel transfer

For participants arriving by train, a hotel minibus or car will be available at Liptovsky Mikulas railway station.

  • 14 Dec 2026 at 14:30: Liptovsky Mikulas rail station [SK] > Permon [SK]
  • 17 Dec 2026 from 8:00: Permon [SK] > Liptovsky Mikulas rail station [SK]
Planned route
  1. 14 Dec 2026: VIE [AT] > BA [SK] > Permon [SK]

  2. 17 Dec 2026: Permon [SK] > BA [SK] > VIE [AT]

Reserve transfer

Accommodation

Accommodation directly at Grand hotel Permon****

Accommodation is paid directly to the hotel at the conference venue. Reservation must be made in writing by e-mail to kongres@hotelpermon.sk.

Check-in Monday 14 December 2026 from 15:00
Check-out Thursday 17 December 2026 by 11:00
Reserve accommodation
1 person in room 160 EUR

incl. VAT / 1 night

480 EUR / 3 nights
2 people in room 200 EUR

incl. VAT / 1 night

600 EUR / 3 nights

The accommodation price includes breakfast, in-room slippers, free swimming in the pool area from 7:00 to 10:00 and parking.

The price does not include accommodation tax: EUR 0.80 / person / day.

Venue

Grand hotel Permon****

The conference takes place in the beautiful surroundings of Grand hotel Permon**** in Podbanské, on the border of the High and Western Tatras. The area is framed by the Kamenistá, Tichá and Kôprová valleys, the majestic Kriváň peak (2,494 m) and the nearby Bystrá peak (2,248 m). The clean Belá river gives Podbanské its exceptional natural character.

Full hotel information is available on the official hotel website .

Podbanské, High Tatras, Slovak Republic

GPS coordinates: 49° 8´ 48.686565″ N / 19° 54´ 28.1399345″ E

Show on map

Registration

Registration is invitation-based

Conference registration is handled through an e-mail invitation. The invitation will include a personal registration link.

This page serves as an informational overview of the conference. If you have not received an invitation and would like to attend, you can request one.

E-mail invitation

Registration information will be sent directly in the e-mail invitation.

Registration link

Registration is completed through the personal link included in the invitation.

Don't have an invitation?

If you have not received an invitation and would like to attend, you can request one.