🇨🇿 Why Is Software Validation Not Enough? A Guide to Medical Device Software Clinical Evaluation According to MDR

The event is held in Czech language only!

During the webinar, we will first introduce the basic concepts and regulatory requirements arising from the MDR in the area of clinical evaluation. We will also explain some of the specific requirements applicable to medical device software. We will examine in detail the practical application of the key guidance document MDCG 2020-1 and thoroughly analyze all necessary areas of evaluation.

We will demonstrate how to methodically document a valid clinical association linking the software to a specific clinical condition, how to evaluate technical performance in terms of algorithm reliability, and how to substantiate the clinical function in relation to patients, including the required level and amount of clinical evidence.

We will supplement the presentation with specific real-world examples, recommendations, examples of the most common nonconformities, and procedures for structuring the documentation so that it passes the certification process without difficulty. We will conclude the webinar with a section on PMCF, focusing on the practical setup of individual activities for collecting clinical data on the software after it has been successfully placed on the market.

Who the webinar is for:

• Software developers and programmers in the healthcare sector

• Researchers in academia who are considering transferring research results into practice

• Regulatory affairs professionals and quality managers at manufacturers of medical device software and devices containing software

• Representatives of start-ups operating in the fields of digital health and telemedicine

• Distributors of medical device software or devices containing software

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

Lecturers:

• Ing. Aleš Martinovský

• Ing. Jakub Musil

Content:

• Basic definitions and key terms for MDSW

• A brief overview of software qualification and classification

• Regulatory requirements under Article 61 and Annex XIV to the MDR

• Application of MDCG 2020-1 – a practical guide to evaluating clinical performance

• Evaluation Pillar I: Demonstration of a valid clinical association for MDSW

• Evaluation Pillar II: Demonstration of the technical performance of MDSW

• Evaluation Pillar III: Demonstration of the clinical function of MDSW

• Most common nonconformities identified by notified bodies in the area of clinical evaluation

• PMCF activities for MDSW

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