🇨🇿 Healthcare Software Part 2 – Navigating the Maze of Regulation and Standards: Market Authorization, Validation, AI
This follow-up seminar will focus on the details of the conformity assessment process for medical SW and medical devices that incorporate SW. The goal is to provide an in-depth understanding of and guidance on implementing standards for SW verification and validation, including cybersecurity issues.
Date
28 May 2026, 09:30 – 12:00
Online: Cisco Webex
About
The event is held in Czech language only!
This follow-up webinar on healthcare software is designed as an advanced guide for manufacturers, developers, and regulatory specialists in the field of healthcare software. The main objective of the webinar is to teach participants how to practically meet the theoretical regulatory requirements set forth by European legislation.
Following an introductory review of key regulatory requirements, the presentation will focus in detail on the healthcare software lifecycle process and the necessary associated documentation. A significant portion will be devoted to practical examples of implementing technical standards for the verification and validation of SaMD. The IEC 62304 and IEC 82304 standards will be presented in detail.
A smaller section will also be devoted to explaining the differences for SiMD cases. Within the framework of technological standards, we will also focus on examples of the implementation of standards for cybersecurity (IEC 81001-5-1), the importance of which continues to grow.
The final section will be dedicated to the highly topical issue of artificial intelligence in healthcare, where we will assess the current status and development of the European Artificial Intelligence Act (AIA) and analyze in detail the expected changes in conformity assessment processes for medical devices containing AI.
Who the webinar is for:
Software developers and programmers in the healthcare sector
Regulatory affairs staff and quality managers at manufacturers of healthcare software and devices containing software
Individuals serving as PRRCs at software manufacturers
Representatives of startups operating in the field of digital healthcare
Healthcare service providers
And anyone involved in the lifecycle of healthcare software who wants to understand regulatory obligations
Lecturers:
Ing. Aleš Martinovský
Ing. Jakub Musil
Guest:
Ing. Martin Koval, Ph.D.
Content:
Recap of key regulatory requirements for medical software
SaMD and requirements for medical software lifecycle processes and their documentation
Examples of implementing technical standards for SaMD verification and validation (IEC 62304, IEC 82304)
Differences in the process for SiMD
Examples of implementing standards for cybersecurity (IEC 81001-5-1)
AI in Healthcare
AI Act – current status and developments, changes in the conformity assessment of medical devices containing AI
Additional information:
During the webinar, participants will have the opportunity to ask questions
Each participant will receive a certificate of participation
A PDF presentation will be sent to all participants
Participation fee:
3.900 CZK excluding VAT
100% cancellation fee applies after bindingly confirmed registration, but with the possibility of sending a replacement participant
Webinar hosted by:
Porta Medica s.r.o.
ID: 03301931, VAT: CZ03301931
Registered office: Opletalova 1525/39, 110 00, Prague 1 - Nové Město