🇨🇿 Healthcare Software Part 1 – The MDR/IVDR Regulatory Maze: Basics, Market Entry Strategies and Telemedicine

The event is held in Czech language only!

This introductory webinar on software in healthcare is designed as a basic guide primarily for manufacturers, developers, and regulatory specialists who wish to gain confidence in the application of regulatory requirements arising from European legislation (MDR, IVDR). The presentation will clearly explain the qualification and definition of software in the field of medical devices and will guide participants in detail through the correct application of qualification and classification rules, including the use of the MDCG 2019-11 guidance document. We will also clarify under which circumstances software used in healthcare is not considered a medical device.

A significant portion will then be devoted to general strategies and parameters of the conformity assessment process, utilizing relevant technical standards and key MDCG documents. Within this section, we will also focus on a practical approach to such a process, whether in the context of risk management, clinical evaluation, or post-market activities. The presentation will also include examples from the field of telemedicine to clarify relevant strategies in this area. 

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

• Representatives of startups operating in the digital healthcare sector

• Providers of telemedicine services

• Distributors of healthcare software or devices containing software

• Healthcare service providers and others who wish to better understand the conformity assessment process for healthcare software

Lecturers:

• Ing. Aleš Martinovský

• Ing. Jakub Musil

Guest:

• Ing. Martin Koval, Ph.D.

Content:

• Introduction to the basic regulatory framework under the MDR and IVDR

• Classification of medical device software (MDSW), categorization and specifics of SaMD and SiMD

• Classification rules for MDSW according to Annex VIII of the MDR/IVDR, application of the MDCG 2019-11 guidance document

• Demonstration of conformity process, overview of technical standards and MDCG documents

• Examples of telemedicine solutions and MDCG 2023-4

• Demonstration of conformity in practice: risk management

• Conformity assessment in practice: clinical evaluation, performance evaluation, PMS, and PMCF/PMPF activities

  
  

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